222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details


臨床試験数 : 285 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05267262
(ClinicalTrials.gov)
March 15, 202223/2/2022Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGCAlport Syndrome;Focal Segmental GlomerulosclerosisDrug: R3R01River 3 Renal Corp.IQVIA BiotechNot yet recruiting12 YearsN/AAll50Phase 2NULL
2NCT05213624
(ClinicalTrials.gov)
March 14, 202227/1/2022A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental GlomerulosclerosisA Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 764198 Administered Orally Once Daily for 12 Weeks in Patients With Focal Segmental GlomerulosclerosisKidney Disease, ChronicDrug: BI 764198;Drug: PlaceboBoehringer IngelheimNULLNot yet recruiting18 Years75 YearsAll60Phase 2NULL
3EUCTR2021-004174-64-DK
(EUCTR)
08/03/202216/12/2021Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosisA pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) - ACTION3 Focal segmental glomerulosclerosis
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10016832;Term: Focal & segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Repagermanium
Product Code: DMX-200
INN or Proposed INN: Repagermanium
Dimerix Bioscience Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
286Phase 3France;United States;Taiwan;Hong Kong;Argentina;Spain;Brazil;Australia;Denmark;United Kingdom;New Zealand;Korea, Republic of
4NCT05050214
(ClinicalTrials.gov)
March 20229/9/2021Obinutuzumab in Primary MNObinutuzumab for Primary Membranous Nephropathy: a Pilot Study in Patients With Rituximab-resistant or Rituximab-dependent Nephrotic Syndrome and in Patients Intolerant to Rituximab (the ORION Study)Membranous NephropathyDrug: ObinutuzumabMario Negri Institute for Pharmacological ResearchRoche S.p.aNot yet recruiting18 YearsN/AAll20Phase 2Italy
5EUCTR2020-003767-25-ES
(EUCTR)
25/02/202225/02/2022A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of
6EUCTR2020-003767-25-NL
(EUCTR)
16/02/202213/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Germany;Netherlands;Japan;Korea, Republic of
7EUCTR2020-003767-25-PL
(EUCTR)
08/02/202209/11/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
8NCT05183646
(ClinicalTrials.gov)
February 202229/11/2021A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARBA Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)FSGSDrug: DMX-200;Drug: PlaceboDimerix Bioscience Pty LtdNULLNot yet recruiting18 Years80 YearsAll286Phase 3Australia;New Zealand
9EUCTR2021-000621-27-IT
(EUCTR)
11/01/202212/10/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: [RE-021]
INN or Proposed INN: Sparsentan
TRAVERE THERAPEUTICS, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
10EUCTR2021-004864-81-IT
(EUCTR)
17/12/202117/09/2021Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION)Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION) - Obinutuzumab in primary MN PRIMARY MEMBRANOUS NEPHROPATHY
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Trade Name: GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO
Product Name: GAZYVARO
Product Code: [L01XC15]
INN or Proposed INN: Obitunuzumab
Trade Name: OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML
Product Name: OMNIPAQUE
Product Code: [Ioexolo]
INN or Proposed INN: ioexolo
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Italy
11NCT04983888
(ClinicalTrials.gov)
November 17, 202121/7/2021Obinutuzumab in Primary FSGSA Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose CorticosteroidsPrimary Focal Segmental GlomerulosclerosisDrug: ObinutuzumabMayo ClinicGenentech, Inc.Recruiting18 YearsN/AAll12Phase 2United States
12NCT05136456
(ClinicalTrials.gov)
November 5, 202117/11/2021Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous NephropathyA Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)Primary Membranous NephropathyDrug: SHR1459 Low Dose;Drug: SHR1459 High Dose;Drug: PlaceboReistone Biopharma Company LimitedNULLRecruiting18 Years75 YearsAll60Phase 2China
13ChiCTR2100048518
2021-10-312021-07-09A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathyA prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathylow-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No;The Second Affiliated Hospital of Xi'an Jiaotong UniversityNULLPending1870Bothlow-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100;China
14NCT05162066
(ClinicalTrials.gov)
October 29, 202126/11/2021BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW)An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMNComplement 3 Glomerulopathy;Immunoglobulin A Nephropathy;Membranous NephropathyDrug: BCX9930BioCryst PharmaceuticalsNULLRecruiting18 YearsN/AAll42Phase 2Italy;Spain
15NCT04893096
(ClinicalTrials.gov)
October 22, 202111/5/2021Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target TherapyRescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target TherapyMembranous NephropathyDrug: MOR202Mario Negri Institute for Pharmacological ResearchMorphoSys AGRecruiting18 YearsN/AAll10Phase 2Italy
16EUCTR2021-000835-30-IT
(EUCTR)
12/10/202130/08/2021MOR202 for refractory MNRESCUE THERAPY WITH THE HUMAN ANTI-CD38 ANTIBODY MOR202 (FELZARTAMAB) IN PATIENTS WITH MEMBRANOUS NEPHROPATHY WHO FAILED ANTI-CD20 TARGETED THERAPY: A PILOT, PROOF-OF-CONCEPT STUDY - MOR202 for refractory MN Membranous Nephropathy who Failed Anti-CD20 Target Therapy.
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Product Name: MOR202
Product Code: [MOR202]
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2Italy
17EUCTR2020-005855-19-ES
(EUCTR)
11/10/202105/08/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
18EUCTR2021-000621-27-ES
(EUCTR)
08/10/202127/07/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States;Poland
19EUCTR2020-005855-19-IT
(EUCTR)
01/10/202122/10/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
20NCT05003986
(ClinicalTrials.gov)
August 12, 202129/7/2021Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular DiseasesFocal Segmental Glomerulosclerosis;Minimal Change Disease;Immunoglobulin A Nephropathy;Immunoglobulin A-Associated Vasculitis;Alport SyndromeDrug: SparsentanTravere Therapeutics, Inc.NULLRecruiting1 Year17 YearsAll57Phase 2United States;Poland;Spain
21ChiCTR2100048382
2021-07-012021-07-06Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical TrialEfficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial Idiopathic membranous nephropathyExperimental group:On the basis of ACEI/ARB, tripterygium wilfordii polyglycoside tablets were added;Control group:The original dose of ACEI/ARB was used for treatment;Department of Nephrology, Sichuan Provincial People's HospitalNULLRecruiting1865BothExperimental group:18;Control group:18;N/AChina
22EUCTR2020-000971-18-NO
(EUCTR)
28/06/202123/02/2021A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effectAn exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 Idiopathic membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 2Denmark;Norway
23NCT04629248
(ClinicalTrials.gov)
June 25, 202127/10/2020A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous NephropathyA Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous NephropathyPrimary Membranous NephropathyDrug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineHoffmann-La RocheNULLRecruiting18 Years75 YearsAll140Phase 3United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru
24EUCTR2020-004176-18-ES
(EUCTR)
21/06/202109/02/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - The AFFINITY Study Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Korea, Republic of
25EUCTR2020-002637-15-FR
(EUCTR)
09/06/202102/02/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
26EUCTR2020-004176-18-IT
(EUCTR)
08/06/202108/06/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
Product Code: [atrasentan]
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
CHINOOK THERAPEUTICS, U.S., IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Italy;Korea, Republic of
27NCT04652570
(ClinicalTrials.gov)
May 5, 202123/11/2020Efficacy and Safety of VB119 in Subjects With Membranous NephropathyA Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous NephropathyMembranous NephropathyDrug: VB119ValenzaBio, Inc.NULLRecruiting18 YearsN/AAll30Phase 1/Phase 2United States;United Kingdom
28NCT04743739
(ClinicalTrials.gov)
April 14, 202130/1/2021Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMNA Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: Rituximab;Drug: cyclosporinePeking Union Medical College HospitalBeijing Tongren Hospital;Chinese Academy of Medical Sciences, Fuwai Hospital;The Luhe Teaching Hospital of the Capital Medical University;The Seventh Affiliated Hospital, Sun Yat-sen University;First Affiliated Hospital of Xinjiang Medical University;Nanyang Nanshi Hospital of Henan University;Shanghai Fosun Pharmaceutical Development Co, Ltd.Recruiting18 Years80 YearsAll126Phase 3China
29NCT04278729
(ClinicalTrials.gov)
April 14, 202118/2/2020A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic SyndromeA Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic SyndromeNephrotic Syndrome;Membranous NephropathyDrug: Apixaban 5 MGUniversity of North Carolina, Chapel HillAmerican College of Clinical PharmacyRecruiting18 Years79 YearsAll30Phase 1United States
30NCT04745728
(ClinicalTrials.gov)
April 14, 20214/2/2021Different Immunosuppressive Treatment in iMNDifferent Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective CohortIdiopathic Membranous NephropathyDrug: Prednisone;Drug: Cyclophosphamide;Drug: RituximabPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll200Phase 3China
31EUCTR2020-003233-38-PL
(EUCTR)
13/04/202124/02/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: RO5072759
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China
32EUCTR2020-002637-15-IT
(EUCTR)
09/04/202104/06/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: [APL-2]
INN or Proposed INN: Pegcetacoplan
Trade Name: Prevenar 13 suspension for injection
Product Name: Prevenar 13 suspension for injection
Product Code: [na]
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg
Trade Name: Pneumococcal polysaccharide vaccine
Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial
Product Code: [na]
INN or Proposed INN: Pneumococcal Polysaccharide Vaccine
Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States
33EUCTR2020-003233-38-IT
(EUCTR)
06/04/202104/06/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: [RO5072759]
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China
34EUCTR2020-002637-15-NL
(EUCTR)
29/03/202104/01/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
35NCT02399462
(ClinicalTrials.gov)
March 20218/1/2015Acthar for Treatment of Post-transplant FSGSActhar for Treatment of Post-transplant FSGSFSGS;Renal Transplantation;Kidney TransplantationDrug: ActharUniversity of North Carolina, Chapel HillMallinckrodtWithdrawn18 YearsN/AAll0Phase 4United States
36NCT04572854
(ClinicalTrials.gov)
February 23, 202129/9/2020Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGNC3G;IC-MPGN;Renal Transplant;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Dense Deposit Disease;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)Drug: PegcetacoplanApellis Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll12Phase 2United States
37NCT04573920
(ClinicalTrials.gov)
February 1, 202128/9/2020Atrasentan in Patients With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular DiseasesIgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A NephropathyDrug: AtrasentanChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll80Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom
38NCT04733040
(ClinicalTrials.gov)
January 20, 202118/1/2021Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)Glomerulonephritis;Membranous Nephropathy;antiPLA2R PositiveDrug: MOR202MorphoSys AGNULLRecruiting18 Years80 YearsAll22Phase 2Georgia;Germany;Greece;Korea, Republic of;Russian Federation;Taiwan;United Kingdom
39ChiCTR2100042674
2021-01-182021-01-26Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort studyStandard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study syndrome diseaseexperimental group:RTX treatment;Jiangsu Province People's HospitalNULLRecruiting1875Maleexperimental group:65;Phase 4China
40EUCTR2019-000780-24-PL
(EUCTR)
07/01/202114/09/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of
41ChiCTR2000037508
2021-01-012020-08-28To build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosisTo build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosis CKD MNHealthy Volunteer Group:NO;MN group:Yiqi Huoxue Huashi Recipe;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1875BothHealthy Volunteer Group:50;MN group:100;China
42ChiCTR2000037467
2020-12-312020-08-28Effect of Tripterygium wilfordii polyglycoside tablets on the inhibition of TM on complement pathway and related inflammatory markers in membranous nephropathyThe complement pathway and related inflammatory factor markers in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathyGold Standard:Cell hemolysis test;Index test:Immunochemiluminescence (ECL) and flow cytometry (FCM) were used to determine the activity of each complement pathway and the target of complement;
Complement hemolysis test is usually used to determine the activity of total complement and single complement component, but it is difficult to be applied to clinical ;
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1880BothTarget condition:40;Difficult condition:40China
43ChiCTR2100041655
2020-12-302021-01-01Effect of thymosin 1 on recurrent minor nephrotic syndrome in adultsA prospective, randomized controlled trial of oral prednisone combined with thymosin 1 in recurrent adult patients with minimal lesions nephrotic syndrome Minimal change nephrotic syndromeOral prednisone:oral prednisone;Oral prednisone combined with thymosin 1 group:Thymosin 1 was injected;Affiliated Hospital of Guangdong Medical UniversityNULLRecruiting1870BothOral prednisone:27;Oral prednisone combined with thymosin 1 group:27;China
44EUCTR2020-002637-15-GB
(EUCTR)
22/12/202023/10/2020Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom
45EUCTR2020-002985-15-DE
(EUCTR)
21/12/202031/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
46EUCTR2019-003607-35-CZ
(EUCTR)
26/11/202026/11/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan
47EUCTR2019-003607-35-SK
(EUCTR)
12/11/202009/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
48EUCTR2019-003607-35-IT
(EUCTR)
03/11/202002/08/2021A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) - - Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: [PF-06730512]
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Czechia;Slovakia;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan
49EUCTR2019-003607-35-DE
(EUCTR)
26/10/202002/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
50EUCTR2019-003607-35-PL
(EUCTR)
23/10/202020/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
51EUCTR2020-002985-15-GR
(EUCTR)
22/10/202011/09/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
52EUCTR2020-002985-15-GB
(EUCTR)
12/10/202025/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
53ChiCTR2000037014
2020-10-012020-08-26The predictive value of gut permeability in children with steroid dependent nephrotic syndromeThe predictive value of gut permeability in children with steroid dependent nephrotic syndrome Primary nephrotic syndromeSteroid sensitive nephrotic syndrome group (SSNS group):Prednisone treatment recommended by the guidelines;Steroid dependent nephrotic syndrome group (SDNS group):Prednisone treatment recommended by the guidelines;Shanghai Children's HospitalNULLPendingBothSteroid sensitive nephrotic syndrome group (SSNS group):40;Steroid dependent nephrotic syndrome group (SDNS group):30;China
54NCT04183101
(ClinicalTrials.gov)
October 1, 202014/11/2019Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 GlomerulopathyPhase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 GlomerulopathyC3 Glomerulopathy;Membranoproliferative Glomerulonephritis;Complement Abnormality;Dense Deposit Disease;C3 GlomerulonephritisDrug: Aliskiren;Drug: EnalaprilRegion SkaneNULLRecruiting6 YearsN/AAll30Phase 2Sweden
55ChiCTR2000038353
2020-09-302020-09-21Effect of levothyroxine on the prognosis of children with PNSEffect of levothyroxine on the prognosis of children with PNS Primary nephrotic syndrometrial group:NS basic treatment + LT4 replacement therapy;control group:after NS basic treatment for 3 weeks, LT4 replacement therapy was started;Chidren's Hospital Affiliated to Capital Institute of Pediatrics, Beijing, ChinaNULLRecruiting116Bothtrial group:90;control group:90;China
56ChiCTR2000032422
2020-09-012020-04-27The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world studyThe efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study Idiopathic membranous nephropathyexperimental group:Tacrolimus;control group:conservative treatment;Shenzhen Second People's HospitalNULLPendingBothexperimental group:24;control group:24;Phase 4Chiina
57NCT04456816
(ClinicalTrials.gov)
August 31, 202024/6/2020A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMNAn Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 4 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: 100 mg AP1189;Drug: PlaceboSynAct Pharma ApsNULLRecruiting18 Years85 YearsAll23Phase 2Denmark
58EUCTR2019-001212-29-DK
(EUCTR)
26/08/202009/06/2020Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndromeCauses and Prevention of Thromboembolic Disease in Nephrotic Syndrome Nephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications.
MedDRA version: 21.1;Level: LLT;Classification code 10029167;Term: Nephrotic syndrome with lesion of membranous glomerulonephritis;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10029165;Term: Nephrotic syndrome in diseases classified elsewhere;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Trade Name: Fragmin
INN or Proposed INN: Dalteparin
Other descriptive name: Dalteparin
Trade Name: Eliquis
INN or Proposed INN: Apixaban
Other descriptive name: Apixaban
Aarhus University Hospital, Henrik BirnNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 1;Phase 2Denmark
59NCT04498962
(ClinicalTrials.gov)
August 202021/7/2020The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket TrialThe Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket TrialChronic Stable Angina;Vascular Dementia;Idiopathic Membranous NephropathyDrug: Danzhu Fuyuan GranuleJingqing HuNULLNot yet recruiting18 Years70 YearsAll240N/AChina
60NCT03970577
(ClinicalTrials.gov)
July 29, 202015/4/2019RItuximab From the FIRst Episode of Idiopathic Nephrotic SyndromeRituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled TrialMinimal Change Nephrotic Syndrome (MCNS)Drug: Rituximab;Drug: PrednisoneAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll148Phase 2France
61NCT04387448
(ClinicalTrials.gov)
July 28, 202011/5/2020A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change DiseaseA Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change DiseaseKidney Diseases;Diabetic Nephropathies;Glomerulosclerosis, Focal Segmental;Nephrosis, Lipoid;Urologic Diseases;Diabetes Complications;Diabetes Mellitus;Endocrine System Diseases;Glomerulonephritis;Nephritis;NephrosisDrug: GFB-887;Drug: PlaceboGoldfinch Bio, Inc.NULLRecruiting18 Years75 YearsAll125Phase 2United States
62ChiCTR2000033766
2020-07-012020-06-11Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimusDiagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus Membranous nephropathy1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus;The First Affiliated Hospital of Bengbu Medical CollegeNULLPending1770Both1:30;2:30;Phase 4China
63EUCTR2020-000185-42-FR
(EUCTR)
12/06/202026/05/2020Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis.A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. APOL1-mediated Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX-147
Product Code: VX-147
INN or Proposed INN: VX147
Other descriptive name: VX-147
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;France;United Kingdom
64NCT04424862
(ClinicalTrials.gov)
June 9, 20207/6/2020Multitarget Therapy for Idiopathic Membranous NephropathyMultitarget Therapy for Idiopathic Membranous NephropathyEfficacyDrug: Prednisone, ciclosporin and mycophenolate mofetil;Drug: Ponticelli RegimenBeijing Friendship HospitalNULLCompleted18 Years70 YearsAll82Phase 4China
65NCT04340362
(ClinicalTrials.gov)
June 8, 20207/4/2020Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental GlomerulosclerosisA Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental GlomerulosclerosisGlomerulosclerosis, Focal SegmentalDrug: VX-147Vertex Pharmaceuticals IncorporatedNULLCompleted18 Years65 YearsAll16Phase 2United States;France;Puerto Rico;United Kingdom
66ChiCTR2000033540
2020-06-012020-06-04Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous NephropathyProspective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy Membranous Nephropathyexperimental group:Rituximab 600mg iv, and supportive treatment;control group:Supportive treatment according to KDIGO guideline;Peking Union Medical College Hospital, Chinese Academy of Medical SciencesNULLRecruiting1870Bothexperimental group:19;control group:19;Phase 4China
67ChiCTR2000032523
2020-06-012020-05-01Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial.Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial membranous nephropathyexperimental group:rituximab;control group:tacrolimus;Xinqiao HospitalNULLPending1880Bothexperimental group:40;control group:40;Phase 4China
68EUCTR2020-000185-42-GB
(EUCTR)
01/06/202023/03/2020Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis.A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. APOL1-mediated Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX-147
Product Code: VX-147
INN or Proposed INN: VX147
Other descriptive name: VX-147
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;United States;United Kingdom
69EUCTR2020-000971-18-DK
(EUCTR)
28/05/202004/04/2020A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effectAn exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 Idiopathic membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 2Denmark
70ChiCTR2000040799
2020-05-202020-12-10Prospective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathyProspective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathySingle arm:Rituximab;The First Affiliated Hospital, Sun Yat-Sen UniversityNULLRecruiting18BothSingle arm:50;Phase 4China
71EUCTR2019-001734-34-NL
(EUCTR)
07/04/202022/08/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China
72ChiCTR2000031003
2020-03-252020-03-20Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimenStudy and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen Idiopathic focal segmental glomerulosclerosisTacrolimus group:Low dose of tacrolimus combined with hormone;hormone group:Use hormones;Southwest Hospital, the First Affiliated Hospital of Army Medical UniversityNULLRecruitingBothTacrolimus group:19;hormone group:19;Phase 4China
73NCT03804359
(ClinicalTrials.gov)
January 14, 202011/1/2019Personalized Medicine for Membranous NephropathyPersonalized Medicine for Membranous NephropathyIdiopathic Membranous NephropathyDrug: RituximabCentre Hospitalier Universitaire de NiceNULLRecruiting18 YearsN/AAll64Phase 2France
74NCT04065438
(ClinicalTrials.gov)
January 1, 202020/8/2019Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 SystemTreatment of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 SystemFocal Segmental GlomerulosclerosisDevice: LIPOSORBER® LA-15Kaneka Medical America LLCNULLRecruiting22 Years75 YearsAll35N/AUnited States
75NCT03949855
(ClinicalTrials.gov)
December 18, 201913/5/2019Belimumab With Rituximab for Primary Membranous NephropathyEfficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)Membranous Nephropathy;Nephrotic SyndromeDrug: Belimumab;Drug: Placebo for Belimumab;Drug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);GlaxoSmithKline;PPD;Rho Federal Systems Division, Inc.Recruiting18 Years75 YearsAll124Phase 2United States;Canada
76NCT04154787
(ClinicalTrials.gov)
November 23, 20198/10/2019Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous NephropathyA Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: LNP023;Drug: RituximabNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll52Phase 2United States;Argentina;China;Czechia;France;Germany;India;Netherlands;Singapore;Spain;Taiwan;United Kingdom
77EUCTR2019-001734-34-ES
(EUCTR)
12/11/201904/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
78EUCTR2019-001734-34-DE
(EUCTR)
30/10/201912/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Germany;Netherlands;China
79ChiCTR1900027128
2019-10-302019-11-01Validation of Anti-Phospholipase A2 Receptor Antibody ELISA in a Chinese Cohort With Idiopathic Membranous Nephropathy: a Multicenter Observational StudyThe Cut-off Value of Anti-Phospholipase A2 Receptor Antibody ELISA in Chinese Patients Membranous NephrologyGold Standard:Pathological diagnosis according to kidney biopsy(Chapter 7, 7.1 Evaluation of MN, KDIGO 2012);Index test:Serum PLA2R Antibody by ELISA;Department of Nephrology, The First Affiliated Hospital of Shandong First Medical UniversityNULLRecruitingBothTarget condition:288;Difficult condition:290N/AChina
80EUCTR2019-000780-24-ES
(EUCTR)
25/10/201926/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands
81EUCTR2019-001734-34-FR
(EUCTR)
23/10/201913/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
82NCT04145440
(ClinicalTrials.gov)
October 15, 201918/10/2019Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)Glomerulonephritis, Membranous;antiPLA2R PositiveDrug: MOR202MorphoSys AGNULLActive, not recruiting18 Years80 YearsAll30Phase 1/Phase 2United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain
83EUCTR2017-003022-32-PL
(EUCTR)
12/10/201920/08/2019An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage)An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome Primary Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CCX140-B
INN or Proposed INN: not available yet
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
13Phase 2United Kingdom;Poland;Canada;France;United States
84EUCTR2019-000780-24-IT
(EUCTR)
08/10/201922/01/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands;Italy
85NCT04009668
(ClinicalTrials.gov)
October 2, 20192/7/2019Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change DiseasePrecision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change DiseaseFSGS;MCD;Focal Segmental Glomerulosclerosis;Minimal Change DiseaseDrug: adalimumabUniversity of MichiganNew York UniversityRecruiting6 Years70 YearsAll8Phase 2United States
86JPRN-UMIN000038242
2019/10/0109/10/2019The effect of Evolocumab on primary nephrotic syndromeThe effect of Evolocumab on primary nephrotic syndrome - The effect of Evolocumab on primary nephrotic syndrome Primary nephrotic syndromeEvolocumabDepartment of Nephrology, Nippon Medical SchoolNULLRecruiting16years-oldNot applicableMale and Female10Not selectedJapan
87EUCTR2019-000780-24-NL
(EUCTR)
24/09/201903/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of
88EUCTR2019-001734-34-GB
(EUCTR)
23/09/201907/08/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
89EUCTR2016-005141-23-PT
(EUCTR)
23/09/201912/04/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Hong Kong;Estonia;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
90EUCTR2019-000780-24-FR
(EUCTR)
23/09/201915/10/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;European Union;Spain;Netherlands
91EUCTR2016-005141-23-SE
(EUCTR)
31/07/201928/03/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Korea, Republic of;Sweden
92EUCTR2016-005141-23-HR
(EUCTR)
25/07/201911/10/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
93EUCTR2016-005141-23-BE
(EUCTR)
15/07/201914/05/2019Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
94NCT03763643
(ClinicalTrials.gov)
July 1, 20197/8/2018PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-TransplantPRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-TransplantFocal Segmental GlomerulosclerosisDrug: Rituximab;Procedure: PlasmapheresisUniversity of MinnesotaUnited States Department of DefenseRecruiting1 Year65 YearsAll160Phase 3United States
95EUCTR2018-004611-50-GB
(EUCTR)
14/06/201911/04/2019The Use of Rituximab IN treatment of immune-mediated Glomerulonephritis (TURING) A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING) - TURING Minimal Change Disease (MCD) and Focal segmental glomerulosclerosis (FSGS)Product Name: Rituximab
INN or Proposed INN: Rituximab
Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
112 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
96EUCTR2016-005141-23-DE
(EUCTR)
28/05/201930/05/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablet
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (NDC# 43547-0374-03 and NDC 43547-374-09, approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (NDC# 31722-729-30 approved in the United states)
Product Name: Over-encapsulated Irbesartan Tablets
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
97EUCTR2016-005141-23-EE
(EUCTR)
07/05/201927/03/2019A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
98EUCTR2018-002476-40-FR
(EUCTR)
07/05/201914/08/2018 Personalized Medicine for Membranous Nephropathy PMMN Personalized Medicine for Membranous Nephropathy PMMN - PMMN Idiopathic Membranous Nephropathy
MedDRA version: 20.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: TRUXIMA
Product Name: TRUXIMAB
CHU de NiceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
99ChiCTR1900022943
2019-05-032019-05-04Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic SyndromePopulation Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome Nephrotic SyndromeCase Series:Tacrolimus;Children's Hospital, Zhejiang University School of MedicineNULLRecruitingBothCase Series:100;Phase 4China
100EUCTR2018-003437-15-FR
(EUCTR)
03/04/201927/02/2019Rituximab from the FIRst Episode of Idiopathic Nephrotic SyndromeRituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS Minimal Change Nephrotic Syndrome (MCNS)
MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARISNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
148 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
101ChiCTR1900021757
2019-03-012019-03-08A randomized controlled trial for hydroxychloroquine sulfate in the treatment of idiopathic membranous nephropathyThe efficacy and safety of hydroxychloroquine sulfate in idiopathic membranous nephropathy: A randomized, controlled, Single-center clinical trial Idiopathic Membranous NephropathyGroup 1:Supportive treatment+Perindopril 8 mg/day;Group 2:Supportive treatment+Perindopril 8 mg/day+hydroxychloroquine sulfate (200mg 2/d);Group 3:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml);Group 4:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)+hydroxychloroquine sulfate (200mg 2/d);Nephrology Division, First Hospital Affiliated to Army Medical UniversityNULLRecruiting1860BothGroup 1:55;Group 2:55;Group 3:55;Group 4:55;Phase 4China
102NCT02683889
(ClinicalTrials.gov)
February 1, 20195/2/2016Use of Acthar in Patients With FSGS That Will be Undergoing Renal TransplantationThe Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal TransplantFSGSDrug: ActharUniversity of Colorado, DenverNULLRecruiting18 Years80 YearsAll20Phase 3United States
103EUCTR2017-002674-39-NL
(EUCTR)
30/01/201918/07/2018A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
104ChiCTR1800019833
2019-01-012018-12-02Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormoneDynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone Idiopathic Membranous NephropathyPLA2R???:Cyclophosphamide combined with hormone therapy ;PLA2R positive Group:Cyclophosphamide combined with hormone therapy;Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityNULLPending1885MalePLA2R???:30;PLA2R positive Group:30;China
105ChiCTR1800020241
2019-01-012018-12-20Investigation for Risk Factors of Membrane Nephropathy in Guangxi and Study for Intervention of Vitamin DDisease diagnosis and treatment technology and standardized research and development and application demonstration Idiopathic membranous nephropathyVitamin D group:Active Vitamin D 0.5ug/day;Valsartan group:Valsartan capsule 160mg/day;Combined treatment group:Active vitamin D 0.5ug / day + valsartan capsule 160mg / day;The People's Hospital of Guangxi Zhuang Autonomous RegionNULLRecruiting14100BothVitamin D group:40;Valsartan group:40;Combined treatment group:40;China
106NCT03864250
(ClinicalTrials.gov)
November 26, 20184/3/2019Tacrolimus Monotherapy for Idiopathic Membranous NephropathyTacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical TrialTacrolimus;Idiopathic Membranous Nephropathy;Clinical TrialDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll124N/AChina
107EUCTR2016-005141-23-PL
(EUCTR)
20/11/201825/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablet
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
108NCT03649152
(ClinicalTrials.gov)
November 8, 20187/8/2018Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving IrbesartanA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving IrbesartanFocal Segmental GlomerulosclerosisDrug: Propagermanium;Drug: PlaceboDimerix Bioscience Pty LtdIqvia Pty LtdActive, not recruiting18 Years80 YearsAll10Phase 2Australia
109EUCTR2016-005141-23-DK
(EUCTR)
05/11/201802/08/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of
110EUCTR2017-003021-15-GB
(EUCTR)
23/10/201814/03/2018A study in which the safety and efficacy of CCX140-B is compared with placebo in patients with Focal Segmental GlomerulosclerosisA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CCX140-BChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;United States;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
111NCT03448692
(ClinicalTrials.gov)
October 15, 201822/2/2018A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)Focal Segmental Glomerulosclerosis (FSGS)Drug: PF-06730512PfizerNULLRecruiting18 YearsN/AAll44Phase 2United States;Canada;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Slovakia;Spain;United Kingdom
112NCT03703908
(ClinicalTrials.gov)
October 1, 201824/7/2018A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic SyndromeAn Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic SyndromeFocal Segmental GlomerulosclerosisDrug: CCX140-BChemoCentryxNULLRecruiting18 YearsN/AAll13Phase 2United States
113EUCTR2016-005141-23-ES
(EUCTR)
28/09/201821/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 75 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of
114EUCTR2016-005141-23-GB
(EUCTR)
18/09/201802/05/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) - DUPLEX (021FSGS16010) Sparsentan in FSGS Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of
115EUCTR2016-005141-23-IT
(EUCTR)
17/09/201815/01/2021Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) - Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis ( Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: [R-021]
Trade Name: Irbesartan
Product Name: IRBESARTAN
Product Code: [SUB08293MIG]
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan
Product Code: [over-encapsulated Irbesartan]
INN or Proposed INN: Irbesartan
Other descriptive name: Irbesartan
RETROPHIN, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Taiwan;Hong Kong;Estonia;Spain;Italy;Switzerland;France;Australia;Denmark;South Africa;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
116EUCTR2016-005141-23-CZ
(EUCTR)
05/09/201813/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan/Over-encapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets
Product Name: Over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Denmark;Germany;New Zealand;Sweden;Korea, Republic of;Australia;Croatia;Belgium;Brazil;Poland;Argentina;Canada;Czech Republic;Hungary;France;Italy;United Kingdom;Spain;Taiwan;Hong Kong;Estonia;Czechia;United States;Portugal
117EUCTR2016-005141-23-HU
(EUCTR)
29/08/201826/06/2018Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 75 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Estonia;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Sweden;Korea, Republic of
118NCT03298698
(ClinicalTrials.gov)
August 22, 201824/8/2017Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic SyndromeEfficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose PrednisoneIdiopathic Nephrotic Syndrome;Minimal Change Disease;Focal Segmental GlomerulosclerosisDrug: Rituximab;Drug: PrednisoneRadboud UniversityNULLRecruiting18 YearsN/AAll40Phase 3Netherlands
119EUCTR2017-002674-39-IT
(EUCTR)
03/08/201808/06/2021A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH0144471 compresse
Product Code: ACH0144471
INN or Proposed INN: ACH-0144471
Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML
Product Name: ACT-HIB
Product Code: [ACT-HIB]
Product Name: Bexsero
Product Code: [Bexsero]
Product Name: Menveo
Product Code: [Menveo]
Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE
Product Name: Prevenar 13
Product Code:
ACHILLION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
120EUCTR2017-001821-42-GB
(EUCTR)
02/08/201812/09/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom
121EUCTR2017-002674-39-BE
(EUCTR)
31/07/201816/05/2018A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
122EUCTR2017-003021-15-IT
(EUCTR)
04/07/201810/11/2020A study to evaluate the efficacy og CCX140-B in patients with FSGSA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) - NA Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: -
Product Code: [CCX140-B]
CHEMOCENTRYX, INC.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;France;Czechia;Canada;Poland;Australia;Germany;United Kingdom;New Zealand;Italy
123NCT03549663
(ClinicalTrials.gov)
July 4, 201810/5/2018Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll108N/AChina
124ChiCTR1800016140
2018-07-012018-05-14Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open studyA randomized controlled trial for the treatment of primary membranous nephropathy primary membranous nephropathyTacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks;Sichuan Provincial People's HospitalNULLPending1865BothTacrolimus group:45;Cyclophosphamide group:45;China
125NCT03170323
(ClinicalTrials.gov)
July 1, 201826/5/2017Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous NephropathyA Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: Mycophenolate Mofetil;Drug: CyclosporinsGuangdong Provincial People's HospitalNULLRecruiting18 YearsN/AAll128Phase 4China
126EUCTR2016-003525-42-NL
(EUCTR)
26/06/201809/01/2018A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Australia;Netherlands
127NCT03598036
(ClinicalTrials.gov)
June 21, 201814/6/2018Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental GlomerulosclerosisAn Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: VoclosporinAurinia Pharmaceuticals Inc.NULLTerminated18 Years75 YearsAll5Phase 2United States;Dominican Republic
128NCT03459443
(ClinicalTrials.gov)
June 20, 201826/2/2018A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471C3 Glomerulonephritis;C3 Glomerulopathy;Immune Complex Membranoproliferative Glomerulonephritis;IC-MPGN;Dense Deposit DiseaseDrug: DanicopanAlexion PharmaceuticalsNULLCompleted12 YearsN/AAll22Phase 2United States;Australia;Belgium;Italy;Netherlands
129EUCTR2017-003021-15-PL
(EUCTR)
19/06/201818/05/2018A controlled study to evaluate the safety and efficacy of the study drug, CCX140-B, in subjects with Focal Segmental Glomerulosclerosis (a type of glomerular disease)A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CCX140-B
INN or Proposed INN: INN not available yet
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;United States;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
130EUCTR2017-003021-15-FR
(EUCTR)
18/05/201813/03/2018Study to determine the dose CCX140-B and to evaluate the its safety and efficacy of in Subjects with Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CCX140-BChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;France;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
131NCT03536754
(ClinicalTrials.gov)
May 1, 201828/3/2018A Study of CCX140-B in Subjects With FSGSA Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)FSGS;Focal Segmental Glomerulosclerosis;GlomerulosclerosisOther: Placebo;Drug: CCX140-BChemoCentryxMedpace, Inc.Completed18 Years75 YearsAll46Phase 2United States;Australia;Canada;France;Italy;New Zealand;Poland;United Kingdom
132NCT03422510
(ClinicalTrials.gov)
April 15, 201830/1/2018FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)Primary Focal Segmental GlomerulosclerosisDrug: CXA-10Complexa, Inc.Kidney Research Network, formerly NephCure Accelerating Cures Institute;Medpace, Inc.;MicroConstants;Arkana Labs;NephCure Kidney InternationalCompleted13 YearsN/AAll33Phase 2United States
133NCT03493685
(ClinicalTrials.gov)
March 29, 20183/4/2018Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGSFocal Segmental GlomerulosclerosisDrug: sparsentan;Drug: IrbesartanTravere Therapeutics, Inc.NULLActive, not recruiting8 Years75 YearsAll371Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;New Zealand;Poland;Portugal;Spain;Sweden;Taiwan;United Kingdom;Hungary
134NCT03466801
(ClinicalTrials.gov)
March 20, 201813/1/2018The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.Idiopathic Membranous NephropathyDrug: Prednisone;Drug: MP and CTXWenhu LiuNULLTerminated18 Years80 YearsAll6N/AChina
135NCT03025828
(ClinicalTrials.gov)
March 19, 201817/1/2017Adrenocorticotropic Hormone in Membranous NephropathyChanges in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous NephropathyMembranous NephropathyDrug: ACTHarIcahn School of Medicine at Mount SinaiNULLCompleted18 Years70 YearsAll5Phase 4United States
136EUCTR2017-001821-42-IT
(EUCTR)
07/03/201814/11/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
137EUCTR2017-001821-42-NL
(EUCTR)
13/02/201816/10/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Canada;Spain;Belgium;Ireland;Denmark;Germany;Netherlands;United Kingdom;Italy
138ChiCTR1800014719
2018-02-012018-01-31A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosisA retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis idiopathic focal segmental glomerulosclerosistacrolimus group:nothing;prednisone group:nothing;the First Affiliated Hospital of Third Military Medical UniversityNULLRecruitingBothtacrolimus group:24;prednisone group:17;China
139NCT03453619
(ClinicalTrials.gov)
January 22, 201827/2/2018Phase II Study Assessing Safety and Efficacy of APL-2 in GlomerulopathiesA Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)IgA Nephropathy;Lupus Nephritis;Membranous Nephropathy;C3 Glomerulonephritis;Dense Deposit DiseaseDrug: APL-2Apellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll21Phase 2United States
140EUCTR2017-001821-42-BE
(EUCTR)
15/01/201806/10/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
141NCT03366337
(ClinicalTrials.gov)
December 26, 20174/12/2017A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXA Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney DiseasesIgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States
142EUCTR2017-001821-42-DK
(EUCTR)
19/12/201725/10/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
143EUCTR2017-001821-42-ES
(EUCTR)
04/12/201724/10/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom
144ChiCTR1900027627
2017-12-012019-11-22Efficacy of leflunomide combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathyEfficacy of leflunomide combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathy f PLA2R-associated primary membranous nephropathyexperimental group:LEF combined with prednisone;control group:yclophosphamide (CTX) combined with prednisone;Department of Nephrology, The First Affiliated Hospital of Bengbu Medical CollegeNULLCompletedBothexperimental group:30;control group:30;Phase 4China
145EUCTR2017-001821-42-IE
(EUCTR)
01/12/201709/01/2018A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
146EUCTR2017-001821-42-DE
(EUCTR)
22/11/201709/10/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
147EUCTR2017-001821-42-FR
(EUCTR)
06/11/201709/11/2017A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: AVACOPAN
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
148NCT03285711
(ClinicalTrials.gov)
October 6, 201714/9/2017Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)Lupus Membranous NephropathyDrug: Filgotinib;Drug: Lanraplenib;Drug: Filgotinib placebo;Drug: Lanraplenib placeboGilead SciencesNULLCompleted18 Years75 YearsAll9Phase 2United States
149ChiCTR-INR-17012070
2017-09-192017-07-20Yongquan acupoint Shenque moxibustion curative effect of traditional Chinese medicine in the treatment of membranous nephropathyYongquan acupoint Shenque moxibustion curative effect of traditional Chinese medicine in the treatment of membranous nephropathy Membranous nephropathyTest group :Yongquan Shenque paste of Chinese medicine with mild moxibustion;control group:Valsartan Tablets;Shijiazhuang Nephropathy HospitalNULLPending1875BothTest group :75;control group:75;China
150NCT03095118
(ClinicalTrials.gov)
September 7, 201720/3/2017Daratumumab in Treatment of PGNMID and C3 GNSingle-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal GammopathyMembranoproliferative GlomerulonephritisDrug: DaratumumabFernando FervenzaNULLActive, not recruiting18 YearsN/AAll10Phase 2United States
151NCT03124368
(ClinicalTrials.gov)
August 9, 201712/4/2017A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGNA Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)C3 Glomerulonephritis;Dense Deposit Disease;Membranoproliferative Glomerulonephritis, Type II;C3 Glomerulopathy;Immune Complex Mediated Membranoproliferative GlomerulonephritisDrug: ACH-0144471Alexion PharmaceuticalsNULLCompleted16 Years65 YearsAll6Phase 2Australia;Belgium;Netherlands
152ChiCTR-INR-17012212
2017-07-282017-08-01Use of sirolimus in patients with primary idiopathic membranous nephropathy: a prospective randomized control trialUse of sirolimus in patients with primary idiopathic membranous nephropathy: a prospective randomized control trial idiopathic membranous nephropathy1:Cyclosporine;2:cyclosporine combined with sirolimus;Renal Division, Peking University First HospitalNULLRecruiting1870Both1:35;2:35;China
153ChiCTR-IPR-17011702
2017-07-012017-06-19Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroidCompare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid membranous nephropathymizoribine group:treated with mizoribine and steroid;cyclophosphamide group:treated with cyclophosphamide and steroid;Tianjin First Central HospitalNULLPending1865Bothmizoribine group:50;cyclophosphamide group:50;China
154NCT03180723
(ClinicalTrials.gov)
July 1, 20173/6/2017Effect of Rituximab in Treatment of Membranoproliferative GlomerulonephritisEffect of Rituximab in Treatment of Primary Membranoproliferative GlomerulonephritisMembranoproliferative GlomerulonephritisDrug: Rituximab;Drug: CyclosporinAssiut UniversityNULLNot yet recruiting18 YearsN/AAll30Phase 3NULL
155ChiCTR-IPR-17011386
2017-06-012017-05-12Study on the Effect and Mechanism of Interleukin - 2 in the Treatment of Idiopathic Membranous NephropathyStudy on the Effect and Mechanism of Interleukin - 2 in the Treatment of Idiopathic Membranous Nephropathy Membranous Nephropathytreatment group:oral CsA, glucosteroid aInterleukin 2nd;Control group:oral CsA and glucosteroid;Shijiazhuang kidney disease hospital Limited companyNULLRecruiting1860Bothtreatment group:50;Control group:50;China
156NCT02921789
(ClinicalTrials.gov)
May 22, 201730/9/2016Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsA Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsKidney Transplantation;Focal Segmental Glomerulosclerosis (FSGS)Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: PrednisoneAstellas Pharma Global Development, Inc.Kyowa Kirin Co., Ltd.Completed18 YearsN/AAll71Phase 2United States;Canada
157NCT02633046
(ClinicalTrials.gov)
October 10, 201615/12/2015Acthar for Treatment-Resistant or Treatment-Intolerant ProteinuriaTreatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)Idiopathic Focal Segmental GlomerulosclerosisDrug: Acthar GelMallinckrodt ARD LLCNULLCompleted18 YearsN/AAll63Phase 4United States;Argentina;Australia;Chile;Mexico;Peru;Turkey;Canada;Hong Kong;New Zealand;Puerto Rico
158NCT02896270
(ClinicalTrials.gov)
October 20166/9/2016Valproic Acid for Idiopathic Nephrotic SyndromeA Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic SyndromeIdiopathic Nephrotic Syndrome;Focal Segmental Glomerulosclerosis;Minimal Change DiseaseDrug: Valproic AcidUniversitair Ziekenhuis BrusselNULLRecruiting18 YearsN/AAll15Phase 2/Phase 3Belgium
159NCT02966717
(ClinicalTrials.gov)
August 201630/10/2016Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease)Renal Insufficiency, Chronic;Nephrotic SyndromeDrug: Rituximab;Drug: conventional therapy;Drug: Mesenchymal stem cellsZhujiang HospitalNULLActive, not recruiting18 Years65 YearsBoth116Phase 2China
160ChiCTR-IPR-16008527
2016-06-012016-05-24Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical studyRituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study Membranous nephropathyCsA group:oral CsA and glucosteroid;RTX group:intravenous RTX;CTX:Intravenous cyclophosphamide and glucosteroid;Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicineNULLCompleted1870BothCsA group:60;RTX group:60;CTX:60;Phase 4China
161JPRN-UMIN000022150
2016/04/3001/05/2016The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. - The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome. primary nephrotic syndromerituximabTokyo Metropolitan Geriatric HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female50Not applicableJapan
162ChiCTR-IPR-16008344
2016-04-192016-04-22A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathyA study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy idiopathic membranous nephropathyA:cyclophosphamide ;B:tacrolimus;Baoji Central HospitalNULLRecruitingBothA:30;B:30;China
163ChiCTR2100045947
2016-04-082021-04-30Effects of hydroxychloroquine on proteinuria of primary membranous nephropathyEffects of hydroxychloroquine on proteinuria of primary membranous nephropathy primary membranous nephropathyHCQ group :hydroxychloroquine;Renal Division, Peking University First HospitalNULLCompletedBothHCQ group :22;N/AChina
164NCT02592798
(ClinicalTrials.gov)
March 1, 201629/10/2015Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)Nephrotic Syndrome;Focal Segmental Glomerulosclerosis;Minimal Change DiseaseDrug: Abatacept;Other: Normal Saline;Other: D5WBristol-Myers SquibbNULLCompleted6 YearsN/AAll36Phase 2United States
165NCT02682407
(ClinicalTrials.gov)
February 201610/2/2016Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Dense Deposit DiseaseIgAN;Lupus Nephritis;MN;C3 GlomerulopathyBiological: OMS721 (narsoplimab)Omeros CorporationNULLRecruiting18 YearsN/AAll54Phase 2United States;Hong Kong
166NCT02610595
(ClinicalTrials.gov)
December 201518/11/2015Study on the Therapeutic Effect of TCM Treatment for MDR MNA Prospective, Multi-center Study of the Chinese Medicine for the Treatment of MDR Membranous Nephropathy in the Traditional Chinese Medicine (a Herbal Formula for Invigorating Spleen and Benefiting qi and Promoting Blood Circulation)Idiopathic Membranous NephropathyDrug: Jianpixiaozhong particles and Wuse DietotherapyShanghai University of Traditional Chinese MedicineFudan University;Ruijin Hospital;Shanghai 6th People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Changhai Hospital;Shanghai Putuo District Center Hospital;ShuGuang Hospital;Shanghai Yueyang Integrated Medicine Hospital;Shanghai Changzheng Hospital;Shanghai Minhang Central Hospital;Zhujiang Hospital;Guangxi Traditional Chinese Medical University;Huashan Hospital;The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Xinqiao Hospital of Chongqing;Guang'anmen Hospital of China Academy of Chinese Medical Sciences;Nanjing University of Traditional Chinese Medicine;Tongji Hospital;Chinese Academy of Sciences;RenJi HospitalNot yet recruiting18 Years75 YearsBoth220N/AChina
167NCT02585804
(ClinicalTrials.gov)
September 201522/10/2015Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial EffectsTreating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: The TRANSLATE StudyFocal Segmental GlomerulosclerosisDrug: DapagliflozinUniversity Health Network, TorontoAstraZeneca;University of Toronto;Toronto General HospitalCompleted18 YearsN/AAll10Phase 4Canada
168NCT02382874
(ClinicalTrials.gov)
May 20153/3/2015Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)Allogenic Adipose Derived Mesenchymal Stromal Cells Transplantation to Improve Kidney Function in Refractory Primary Nephrotic Syndrome (Focal Segmental Glomerulosclerosis,FSGS) ,a Phase I Clinical TrialFocal Segmental GlomerulosclerosisBiological: Intravenous injectionRoyan InstituteNULLRecruiting2 Years14 YearsBoth5Phase 1Iran, Islamic Republic of
169EUCTR2014-002358-38-CZ
(EUCTR)
28/04/201514/10/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czech Republic;Belgium;Italy
170EUCTR2013-000226-55-NL
(EUCTR)
04/03/201524/06/2014SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHYEuropean Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN Primary membranous nephropathy
MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Tacrolimus
Product Name: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Other descriptive name: TACROLIMUS
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE ACETATE
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Fundacion Renal Iñigo Alvarez ToledoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
175Spain;Netherlands
171NCT02235857
(ClinicalTrials.gov)
March 20156/9/2014Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in ChildrenTreatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 SystemFocal Segmental GlomerulosclerosisDevice: LIPOSORBER® LA-15 SystemKaneka Medical America LLCNULLRecruitingN/A21 YearsAll35N/AUnited States
172EUCTR2014-002358-38-BE
(EUCTR)
05/02/201525/11/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 17.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Czech Republic;Belgium;Italy
173EUCTR2014-002358-38-IT
(EUCTR)
15/12/201419/11/2014PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
MedDRA version: 17.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
Trade Name: Aprovel (150 mg)
Product Name: Aprovel 150 mg Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Czech Republic;Belgium;Italy
174ChiCTR-TRC-14005064
2014-09-012014-08-06A prospective study on the safety and efficacy of treatment with Qiluxiaobai formula for CKD 2-3 stageInvestigation on the Mechanisms Of Invigorating Spleen Dissipating Dampness Principle On The Treatment Of Podocyte Injury In Focal Segmental Glomerulosclerosis chronic kidney disease1:basic treatment and losartan K 50mg qd;2:basic treatment and QLXB formula 200ml qd ;Shanghai University of T.C.MNULLRecruiting1860Both1:50;2:50;China
175ChiCTR-IPR-14005366
2014-09-012014-01-10A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapyA prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy Atypical membranous nephropathyLow-dose hormone plus cyclophosphamide (CTX) grou:hormone, cyclophosphamide, three months;hormone+CsA:hormone+CsA, three months;Department of Nephrology, China-Japan Friendship HospitalNULLRecruiting1870BothLow-dose hormone plus cyclophosphamide (CTX) grou:20;hormone+CsA:20;NULL
176NCT02000440
(ClinicalTrials.gov)
July 1, 201427/11/2013A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)Study of Losmapimod to Reduce Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis (FSGS)Glomerulosclerosis, Focal SegmentalDrug: LosmapimodGlaxoSmithKlineNULLCompleted18 Years70 YearsAll17Phase 2United States;Canada
177NCT02173106
(ClinicalTrials.gov)
June 201423/6/2014A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous NephropathyOpportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical TrialIdiopathic Membranous Nephropathy;Proteinuria;Spontaneous Remission;Steroid Nephropathy;Cyclosporin OverdoseDrug: steroid & CyclosporinSun Yat-sen UniversityNULLRecruiting14 Years75 YearsBoth180Phase 2China
178NCT02093533
(ClinicalTrials.gov)
March 201417/3/2014Eculizumab in Primary MPGNEVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIAMembranoproliferative GlomerulonephritisDrug: EculizumabMario Negri Institute for Pharmacological ResearchAlexion Pharma Italy s.r.l.CompletedN/A75 YearsAll10Phase 2Italy
179NCT01613118
(ClinicalTrials.gov)
March 20144/6/2012Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental GlomerulosclerosisEfficacy and Safety of RE-021, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation StudyFocal Segmental GlomerulosclerosisDrug: RE-021 (Sparsentan);Drug: IrbesartanTravere Therapeutics, Inc.NULLActive, not recruiting8 Years75 YearsAll109Phase 2United States;Czechia;Italy;Belgium;Czech Republic
180EUCTR2013-003826-10-IT
(EUCTR)
24/01/201428/10/2013ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA - Eculizumab in primary MPGN Membranoproliferative glomerulonephritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
IRCCS- Mario Negri InstituteNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
181NCT01955187
(ClinicalTrials.gov)
January 201419/9/2013Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous NephropathyEuropean Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)MEMBRANOUS NEPHROPATHYDrug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDEHospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, AachenCompleted18 YearsN/AAll86Phase 3Spain
182NCT01573533
(ClinicalTrials.gov)
October 20135/4/2012A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGSA Pilot Study to Assess the Efficacy of Rituximab Therapy in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS): Integrating an Assessment of the Relevance of suPAR and Activation of Podocyte ß3 IntegrinPrimary Focal Segmental GlomerulosclerosisBiological: RituximabMayo ClinicUniversity Health Network, Toronto;National Institutes of Health (NIH);Genentech, Inc.;Rush University Medical Center;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed6 Years80 YearsAll9Phase 2United States;Canada
183EUCTR2012-002365-35-DE
(EUCTR)
15/07/201311/03/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
184NCT01622738
(ClinicalTrials.gov)
July 201313/6/2012A Study of RE-021 in Patients With Focal Segmental GlomerulosclerosisA Study of RE-021 in Patients With Focal Segmental GlomerulosclerosisPrimary Focal Segmental GlomerulosclerosisDrug: RE-021Retrophin, Inc.NULLWithdrawnN/A50 YearsBoth0N/AUnited States
185EUCTR2012-002365-35-IT
(EUCTR)
22/05/201320/03/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 15.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
186EUCTR2012-002365-35-ES
(EUCTR)
19/04/201309/04/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
187NCT01762852
(ClinicalTrials.gov)
April 20134/1/2013Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous NephropathyBEL114674: A 2 Year Study of Efficacy and Safety of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: Belimumab 10 mg;Drug: PlaceboGlaxoSmithKlineNULLWithdrawn18 Years75 YearsAll0Phase 2United States;Australia;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
188EUCTR2011-000242-38-CZ
(EUCTR)
14/02/201313/11/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy
189EUCTR2011-000242-38-DE
(EUCTR)
09/01/201325/09/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom
190NCT01791686
(ClinicalTrials.gov)
January 201329/1/2013Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit DiseaseA Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit DiseaseDense Deposit Disease;Membranoproliferative Glomerulonephritis Type II;C3 GlomerulonephritisDrug: CDX-1135Celldex TherapeuticsNULLTerminated4 YearsN/ABoth1Phase 1United States
191EUCTR2011-000242-38-ES
(EUCTR)
20/12/201222/10/2012A 2 year study to investigate belimumab in membranous nephropathyA 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
192EUCTR2011-000242-38-IT
(EUCTR)
22/11/201211/12/2012A 2 year study to investigate belimumab in membranous nephropathyA 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA
INN or Proposed INN: BELIMUMAB
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
94United States;Czech Republic;Canada;Spain;Germany;United Kingdom;Italy
193EUCTR2011-000242-38-GB
(EUCTR)
01/11/201203/10/2012 A 2 year study to investigate belimumab in membranous nephropathy BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
194JPRN-UMIN000008919
2012/09/1514/09/2012The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy. The patients with nephrotic syndrome due to primary membranous nephropathy.Treatment with a combination of mizoribine plus steroid therapy
Treatment with steroid monotherapy
The study group of treatment for aged patients with nephrotic syndrome.NULLComplete: follow-up complete65years-oldNot applicableMale and Female200Not applicableJapan
195NCT01665391
(ClinicalTrials.gov)
August 201213/8/2012A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental GlomerulosclerosisPrimary Focal Segmental GlomerulosclerosisDrug: fresolimumab;Drug: PlaceboGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth36Phase 2United States;Brazil;Germany;Italy;Spain
196NCT01763580
(ClinicalTrials.gov)
July 16, 20126/12/2012A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic SyndromeOpen-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)MCNS;Minimal Change Nephrotic Syndrome (MCNS)Drug: Tacrolimus;Drug: PrednisoloneAstellas Pharma Korea, Inc.NULLCompleted16 Years78 YearsAll144Phase 4Korea, Republic of
197EUCTR2011-006115-59-IT
(EUCTR)
11/06/201208/06/2012A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011 MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp
MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Trade Name: URBASON*IM EV 1F 250MG+1F 5ML
Trade Name: MEDROL*10CPR DIV 4MG
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
198EUCTR2012-000385-38-GB
(EUCTR)
18/05/201202/04/2012A study to investigate belimumab in IMGN BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy Idiopathic Membranous Glomerulonephropathy (IMGN)
MedDRA version: 16.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA® (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: Belimumab
GlaxoSmithKline Research and Development LtdNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
199NCT01164098
(ClinicalTrials.gov)
February 201215/7/2010Rituximab to Prevent Recurrence of ProteinuriaThe Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGSFSGS;ProteinuriaDrug: RituximabGeorge W. BurkeGenentech, Inc.;National Institutes of Health (NIH);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated7 Years65 YearsAll30Phase 3United States
200NCT01508468
(ClinicalTrials.gov)
January 17, 20129/12/2011Evaluate Rituximab Treatment for Idiopathic Membranous NephropathyProspective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll80Phase 3France
201ChiCTR-INR-15007440
2012-01-012015-10-30Multitarget Therapy for Treatment of Refractory idiopathic membranous nephropathyMultitarget Therapy for Treatment of Refractory idiopathic membranous nephropathy idiopathic membranous nephropathy1:Pred 1mg/kg+MMF 0.5Q12h+FK506 2mg Q12h ;2:Pred 1mg/kg+FK506 2mg Q12h;3:Pred 1mg/kg+CTX50mg BID;The first affiliated hospital of Zhengzhou UniversityNULLRecruiting1865Both1:50;2:50;3:50;China
202NCT03018535
(ClinicalTrials.gov)
January 20129/1/2017Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyA Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: Rituximab;Drug: Methylprednisolone;Drug: CyclophosphamideAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina GasliniActive, not recruiting18 YearsN/AAll76Phase 3Italy
203NCT01845688
(ClinicalTrials.gov)
November 201129/4/2013Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous NephropathyEfficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical StudyIdiopathic Membranous NephropathyDrug: Losartan Tablets & QingReMoShen Granule;Drug: Losartan Tablets & Placebo GranulewanglinNULLActive, not recruiting18 Years70 YearsBoth72N/AChina
204NCT01180036
(ClinicalTrials.gov)
November 201110/8/2010MEmbranous Nephropathy Trial Of RituximabA Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: Rituximab;Drug: CyclosporineMayo ClinicColumbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family FoundationCompleted18 Years80 YearsAll130Phase 2/Phase 3United States;Canada
205NCT01451489
(ClinicalTrials.gov)
October 13, 20115/8/2011The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental GlomerulosclerosisA Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental GlomerulosclerosisFSGSDrug: FK506;Drug: CyclophosphamideNanjing University School of MedicineNULLTerminated14 Years65 YearsAll70N/AChina
206ChiCTR-TRC-11001454
2011-08-012011-08-08Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trialTacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial minimal change disease in adults;ICD10:N04.001Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape;Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLCompletedBothGroup A:60;Group B:60;China
207NCT01386554
(ClinicalTrials.gov)
August 201129/6/2011Acthar for Treatment of Proteinuria in Membranous Nephropathy PatientsA Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)Proteinuria;Idiopathic Membranous NephropathyDrug: Repository Corticotropin Injection;Drug: PlaceboMallinckrodtNULLCompleted18 YearsN/AAll60Phase 4United States;Canada;Chile;Mexico;Turkey
208JPRN-UMIN000005231
2011/03/0110/03/2011Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) steroid dependent and frequently relapsing minimal change nephrotic syndromerituximab 375mg/m2 single-dose
1 time/6months
24 months follow up
Department of Medicine, Kidney Center, Tokyo Women&#39;s Medical UniversityNULLComplete: follow-up complete20years-old60years-oldMale and Female50Phase 3Japan
209NCT01282073
(ClinicalTrials.gov)
March 201119/1/2011Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous NephropathyA Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous NephropathyGlomerulonephritis, MembranousDrug: Mycophenolate mofetil, low dose steroid;Drug: Cyclosporin, low dose steroidKyungpook National UniversityHanmi Pharmaceutical Company LimitedRecruiting18 YearsN/ABoth62Phase 3Korea, Republic of
210NCT00977977
(ClinicalTrials.gov)
December 2, 201015/9/2009Rituximab Plus Cyclosporine in Idiopathic Membranous NephropathyRituximab Plus Cyclosporine in Idiopathic Membranous NephropathyNephrotic Syndrome;Proteinuria;Autoimmune Disease;Glomerular Disease;Membranous GlomerulonephritisDrug: Rituximab Infusion;Drug: Oral CyclosporineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLRecruiting18 YearsN/AAll30Phase 2United States
211NCT01799460
(ClinicalTrials.gov)
December 20108/1/2013Study on Single-nucleotide-polymorphism in Idiopathic Membranous NephropathyMechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association StudiesIdiopathic Membranous NephropathyDrug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine;Drug: The immunosuppressive agentsShanghai University of Traditional Chinese MedicineNULLRecruiting18 Years70 YearsBoth80N/AChina
212NCT01093781
(ClinicalTrials.gov)
November 201024/3/2010Aliskiren in Patients With Idiopathic Membranous NephropathyA Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: AliskirenMayo ClinicNULLWithdrawn18 Years80 YearsBoth0N/AUnited States
213ChiCTR-TRC-10000871
2010-09-012010-05-21A randomized post-market trial of Huang Qi Huai for chilhood steroid-sensitive nephrotic syndromeA randomized post-market trial of Huang Qi Huai for chilhood steroid-sensitive nephrotic syndrome Steroid-sensitive primary nephrotic syndrome in childrenGroup A:Prednisolone (tablets) + Huai Qi Huang (particle);Group B:Prednisolone (tablets) + placebo (particle);Children's Hospital Affiliated to Fudan UniversityNanjing Children's HospitalNULLCompleted112BothGroup A:50;Group B:50;China
214NCT01185197
(ClinicalTrials.gov)
September 201013/8/2010Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized StudyMyfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic SyndromeNephrosis, LipoidDrug: Myfortic plus low-dose steroid;Drug: PrednisoloneThe University of Hong KongNULLCompleted18 Years65 YearsAll20Phase 4China
215NCT01221181
(ClinicalTrials.gov)
July 201013/10/2010Eculizumab Therapy for Dense Deposit Disease and C3 NephropathyEculizumab Therapy for Dense Deposit Disease and C3 NephropathyDense Deposit Disease;Membranoproliferative GlomerulonephritisDrug: EculizumabColumbia UniversityAlexion PharmaceuticalsCompleted18 YearsN/AAll6Phase 1United States
216NCT01162005
(ClinicalTrials.gov)
July 201012/7/2010Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenTherapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenNephrotic SyndromeDrug: TacrolimusSeoul National University HospitalChong Kun Dang PharmaceuticalCompletedN/A18 YearsAll77Phase 4Korea, Republic of
217NCT01161459
(ClinicalTrials.gov)
June 201012/7/2010Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus SteroidResearch Institute of Nephrology, Jinling HospitalIdiopathic Membranous NephropathyDrug: Tripterygium wilfordii;Drug: FK506Zhi-Hong Liu, M.D.NULLCompleted18 Years65 YearsBoth100N/AChina
218EUCTR2009-016003-26-GB
(EUCTR)
06/05/201017/03/2010RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : MyforticRANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
INN or Proposed INN: mycophenolic acid
Other descriptive name: mycophenolate sodium
Trade Name: Myfortic
Product Name: Myfortic 180mg Tablets
INN or Proposed INN: mycophenolic sodium
Other descriptive name: mycophenolate sodium
Product Name: Prednisolone
INN or Proposed INN: prednisolone
UHB NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United Kingdom
219NCT01093157
(ClinicalTrials.gov)
February 201024/3/2010A Dose Escalation Study of Long-acting ACTH Gel in Membranous NephropathyA Dose-finding Pilot Study of ACTH (Adrenocorticotropic Hormone) on the Proteinuria and Serum Lipoprotein Profile in Patients With Idiopathic Membranous Nephropathy (MN)GlomerulonephritisDrug: Adrenocorticotrophic hormone ACTHUniversity Health Network, TorontoMallinckrodtCompleted18 Years72 YearsAll10Phase 1/Phase 2Canada
220ChiCTR-TQR-12002602
2009-10-092012-10-16The Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change NephropathyThe Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change Nephropathy Minimal change nephrotic syndrome in childrenTreatment:prednisone 1~2 mg/kg/day+Fluvastatin Sodium Capsule;Control:prednisone 1~2 mg/kg/day;Treatment center of kidney disease, 281th hospital of PLANULLCompleted412BothTreatment:30;Control:30;I (Phase 1 study)China
221NCT01197040
(ClinicalTrials.gov)
October 20097/9/2010Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic SyndromeLow Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic SyndromeNephrotic SyndromeDrug: Prednisone;Drug: acid mycophenolic (Myfortic)Assistance Publique - Hôpitaux de ParisNovartisCompleted18 YearsN/AAll117Phase 3France
222NCT01113385
(ClinicalTrials.gov)
October 200928/4/2010Oral Galactose in Children With Steroid Resistant Nephrotic SyndromeEffect of Oral Galactose on the Level of Focal Sclerosis Permeability Factor and Proteinuria in Children With Steroid Resistant Nephrotic Syndrome: A Pilot StudyFocal Segmental Glomerulosclerosis;Steroid Resistant Nephrotic SyndromeDrug: D-GalactoseChildren's Research InstituteNational Kidney FoundationCompleted2 Years21 YearsAll7N/AUnited States
223NCT01129557
(ClinicalTrials.gov)
September 200921/5/2010Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney DiseaseAldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney DiseaseProteinuric Kidney Disease;Diabetic Nephropathy;Hypertensive Nephrosclerosis;IgA Nephropathy;Focal Segmental Glomerulosclerosis;Glomerulopathy (Obesity-associated);Glomerulonephritis, MembranousDrug: Aliskiren;Drug: ValsartanColumbia UniversityNovartis PharmaceuticalsTerminated18 YearsN/AAll46Phase 4United States
224NCT01155141
(ClinicalTrials.gov)
September 200929/6/2010Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTHIdiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTHKidney DiseasesDrug: H.P. Acthar GelStanford UniversityMallinckrodtCompleted16 Years65 YearsAll15Phase 4United States
225NCT00956059
(ClinicalTrials.gov)
September 200910/8/2009Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental GlomerulosclerosisTherapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: prednisone, FK506, MMF;Drug: prednisoneXi’an Jiaotong University College of MedicineNULLNot yet recruiting16 Years70 YearsBoth40N/AChina
226EUCTR2008-006750-17-IT
(EUCTR)
14/04/200927/01/2009A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMOA prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS.
MedDRA version: 9.1;Level: LLT;Classification code 10029171
MedDRA version: 9.1;Classification code 10058326
MedDRA version: 9.1;Classification code 10016832
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
227NCT00981838
(ClinicalTrials.gov)
April 200921/9/2009Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS)A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Steroid-dependant or Multirelapsing Minimal Change Disease or Focal Segmental Glomerulosclerosis (NEMO Study)Nephrotic SyndromeDrug: RituximabMario Negri Institute for Pharmacological ResearchAgenzia Italiana del FarmacoCompleted2 Years80 YearsBoth24Phase 3Italy
228ChiCTR-ONC-12002809
2009-01-012012-05-24Clinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic SyndromeClinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic Syndrome Idiopathic nephrotic syndrome1:Given methylprednisolone according to the status of the patients ;The First Affiliated Hospital of Dalian Medical UniversityNULLCompleted1875Both1:90;China
229NCT00805753
(ClinicalTrials.gov)
January 20099/12/2008Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous NephropathyA Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)Idiopathic Membranous NephropathyDrug: ACTHMayo ClinicQuestcor Pharmaceuticals, Inc.Completed18 YearsN/ABoth20Phase 1United States;Canada
230NCT00801463
(ClinicalTrials.gov)
January 20092/12/2008Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental GlomerulosclerosisPrednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental GlomerulosclerosisProteinuria;Focal Segmental GlomerulosclerosisDrug: tripterygium wilfordii (TW)Nanjing University School of MedicineNULLCompleted18 Years60 YearsBoth67N/AChina
231NCT00816478
(ClinicalTrials.gov)
December 200831/12/2008Effect of Oral Galactose on Focal Segmental Glomerulosclerosis (FSGS) Permeability FactorEffect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental GlomerulosclerosisDrug: GalactoseNorth Shore Long Island Jewish Health SystemNULLTerminated2 Years60 YearsBoth15Phase 1United States
232NCT00814255
(ClinicalTrials.gov)
December 200822/12/2008Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical TrialNovel Therapies for Resistant Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: Adalimumab;Drug: Lisinopril, losartan, and atorvastatin;Drug: galactoseNew York University School of MedicineUniversity of Michigan;The Cleveland Clinic;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed1 Year65 YearsAll32Phase 2United States;Canada
233NCT00816504
(ClinicalTrials.gov)
December 200831/12/2008Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)and Chronic Kidney Disease Stage 5Focal Segmental GlomerulosclerosisDrug: GalactoseNorth Shore Long Island Jewish Health SystemMedical College of WisconsinWithdrawn2 Years60 YearsBoth0Phase 1United States
234NCT00694863
(ClinicalTrials.gov)
July 20089/6/2008Treatment With Synthetic ACTH in High Risk Patients With Membranous NephropathyTreatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot StudyIdiopathic Membranous NephropathyDrug: tetracosactide hexacetaatRadboud UniversityDutch Kidney FoundationCompleted18 Years95 YearsBoth20Phase 2Netherlands
235EUCTR2007-005410-39-ES
(EUCTR)
11/06/200808/04/2008Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTACEstudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto.
MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy
Trade Name: Advagraf 0,5mg
INN or Proposed INN: tacrolimus
Trade Name: Genoxal
INN or Proposed INN: ciclofosfamida
Trade Name: Dacortín 2,5mg
INN or Proposed INN: prednisona
Trade Name: Advagraf 1mg
INN or Proposed INN: tacrolimus
Trade Name: Advagraf 5mg
INN or Proposed INN: tacrolimus
Trade Name: Dacortín 5mg
INN or Proposed INN: prednisona
Trade Name: Dacortín 30mg
INN or Proposed INN: prednisona
Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Spain
236EUCTR2008-001647-19-NL
(EUCTR)
22/05/200804/06/2008Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMeNTreatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMeN Membranous nephropathy
MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy
Trade Name: Synacthen Depot 1mgRadboud University Nijmegen Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
237ChiCTR-TRC-08000098
2008-04-012008-04-14Reseaech on integrated therapy of traditional Chinese medicine for membranous nephropathyReseaech on integrated therapy of traditional Chinese medicine for membranous nephropathy Idiopathic membranous nephropathyTreatment group:Integrated therapy of TCM;Control group:Prednisone and CTX;Longhua Hospital Affiliated to Shanghai University of TCMNULLCompleted1875BothTreatment group:95;Control group:95;I (Phase 1 study)China
238NCT00782561
(ClinicalTrials.gov)
April 200827/10/2008Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: FG-3019FibroGenNULLTerminated12 Years64 YearsAll2Phase 1United States
239ChiCTR-TRC-10001024
2008-01-012010-09-14Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosisTacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis primary focal segmental glomerulosclerosisgroup A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;Shanghai Jiaotong University Affiliated Ruijin HospitalNULLCompleted1875Bothgroup A:30;group B:30;China
240NCT00550342
(ClinicalTrials.gov)
January 200826/10/2007Rituximab Treatment of Focal Segmental GlomerulosclerosisAnti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental Glomerulosclerosis (FSGS)Drug: rituximabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Genentech, Inc.;Indiana UniversityCompleted5 Years60 YearsAll10Phase 2United States
241JPRN-UMIN000001099
2007/10/0131/03/2008Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome idiopathic membranous nephropathy associated with nephrotic syndromeSteroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.)
Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted.
Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of MedicineNULL16years-oldNot applicableMale and Female50Phase 4Japan
242JPRN-UMIN000000963
2007/10/0101/01/2010Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome Minimal change nephrotic syndromeadministration of cyclosporineYoshihiko SaitoNULLComplete: follow-up complete20years-old75years-oldMale and Female30Not applicableJapan
243NCT00479622
(ClinicalTrials.gov)
August 200725/5/2007Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusA Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: TRU-015Wyeth is now a wholly owned subsidiary of PfizerEmergent Product Development Seattle LLCTerminated18 Years70 YearsBoth20Phase 1United States
244NCT00518219
(ClinicalTrials.gov)
July 200716/8/2007To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)To Compare the Efficacy and Safety of TW vs Valsartan in the MNMembranous NephropathyDrug: TWNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth68Phase 4China
245NCT00464321
(ClinicalTrials.gov)
May 200720/4/2007Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGSA Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental GlomerulosclerosisBiological: GC1008Genzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth16Phase 1United States;Germany;Italy;United Kingdom
246JPRN-UMIN000000621
2007/03/0128/02/2007Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission Minimal change nephrotic syndromePrednisolone (+), combination therapy (-)
Prednisolone (+), combination therapy (+)
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, JapanNULLComplete: follow-up complete16years-oldNot applicableMale and Female50Not selectedJapan
247NCT00405340
(ClinicalTrials.gov)
October 200629/11/2006Rituximab in the Treatment of Idiopathic Membranous NephropathyRituximab in the Treatment of Idiopathic Membranous NephropathyMembranous NephropathyDrug: RituximabMayo ClinicGenentech, Inc.Completed18 YearsN/ABoth20Phase 0United States
248NCT00354731
(ClinicalTrials.gov)
August 200618/7/2006Efficacy of Pentoxifylline on Primary Nephrotic SyndromeClinical Efficacy of Pentoxifylline on Patients With Primary Nephrotic SyndromeNephrotic SyndromeDrug: pentoxifylline;Drug: CorticosteroidNational Taiwan University HospitalNational Science Council, TaiwanCompleted20 Years80 YearsBoth62Phase 3Taiwan
249ChiCTR-OPN-17012789
2006-06-012017-09-25Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuriaGlucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria focal segmental glomerulosclerosisstudy group:prednisone treatment;control group:ACEI/ARB;Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineNULLCompleted1780Bothstudy group:52;control group:50;China
250EUCTR2005-004469-40-BE
(EUCTR)
12/05/200605/12/2005Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathyMulticenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy Membranous NephropathyTrade Name: Neoral
Product Name: Neoral
Trade Name: zestril
Product Name: zestril
Hopital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Belgium
251EUCTR2005-004460-22-BE
(EUCTR)
12/05/200605/12/2005Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis.Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis. focal and segmental glomerulosclerosisTrade Name: Neoral
Product Name: Neoral
Trade Name: Medrol
Product Name: Medrol
Trade Name: zestril
Product Name: zestril
Hopital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Belgium
252JPRN-C000000158
2006/03/0101/04/2006Mizoribin for primary nephrotic syndrome in children(JSRDC09) Steroid-sensitive nephrotic syndromemizoribine+prednisoloneJapanese Study Group of Renal Disease in Children(JSRDC)NULLComplete: follow-up complete1years-old10years-oldMale and Female50Not selectedJapan
253NCT00302536
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Focal Segmental GlomerulosclerosisTacrolimus Treatment of Patients With Idiopathic Focal SegmentalFocal GlomerulosclerosisDrug: TacrolimusNanjing University School of MedicineNULLWithdrawn15 Years50 YearsBoth0N/AChina
254NCT00983034
(ClinicalTrials.gov)
March 200621/9/2009The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous NephropathyProspective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous NephropathyNephrotic Syndrome;Glomerulonephritis;Membranous NephropathyDrug: lansoprazole, amoxicillin, clarithromycinIstanbul UniversityNULLCompleted18 Years70 YearsBoth70N/ATurkey
255NCT00302523
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Membranous NephropathyTacrolimus Treatment of Patients With IdiopathicIdiopathic Membranous NephropathyDrug: TacrolimusNanjing University School of MedicineNULLCompleted18 Years60 YearsBoth16N/AChina
256NCT00275613
(ClinicalTrials.gov)
November 200510/1/2006Pilot Study of Rituximab for Membranoproliferative GlomerulonephritisPilot Study of Rituximab for Membranoproliferative GlomerulonephritisGlomerulonephritis, MembranoproliferativeDrug: RituximabMayo ClinicNULLCompleted18 YearsN/ABoth10Phase 1United States
257NCT00193648
(ClinicalTrials.gov)
July 200510/9/2005Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)Novel Therapies for Resistant FSGSFocal GlomerulosclerosisDrug: Rosiglitazone (Avandia);Drug: Adalimumab (Humira)North Shore Long Island Jewish Health SystemUniversity of North Carolina;The Cleveland ClinicCompleted2 Years40 YearsBoth21Phase 1United States
258JPRN-UMIN000004653
2005/01/0102/12/2010The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS minimal change nephrotic syndromecyclosporine A 2-3mg/kg/dayYokohama city university graduate school of medicineNULLComplete: follow-up continuing16years-oldNot applicableMale and Female20Not applicableJapan
259NCT00135811
(ClinicalTrials.gov)
November 200424/8/2005Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)Focal Segmental Glomerulosclerosis Clinical TrialGlomerulosclerosis, FocalDrug: Cyclosporin;Drug: MMF and DexamethasoneNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The Cleveland ClinicCompleted2 Years40 YearsBoth207Phase 3United States
260NCT00362531
(ClinicalTrials.gov)
November 20049/8/2006Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromePhase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromeIdiopathic Membranous Nephropathy;Nephrotic SyndromeDrug: tacrolimus combined with prednisonePeking UniversityNULLCompleted18 Years70 YearsBothPhase 2/Phase 3NULL
261NCT00425217
(ClinicalTrials.gov)
August 200419/1/2007Rituximab in Membranous NephropathyThe Use of Rituximab in the Treatment of Idiopathic Membranous NephropathyMembranous NephropathyDrug: RituximabMayo ClinicGenentech, Inc.Completed18 YearsN/ABoth15Phase 2/Phase 3United States
262JPRN-C000000369
2004/04/0127/03/2006Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndromeCyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks
CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks
Project team for treatment of refractory nephrotic syndromeThe Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, JapanComplete: follow-up complete16years-old75years-oldMale and Female300Not selectedJapan
263JPRN-C000000368
2004/04/0127/03/2006Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome membranous nephropathy with primary steroid resistant nephrotic syndromemizoribine once a day per os administration (150mg) after breakfast for 2years.



mizoribine 3 times a day per os administration (50mg each) after meals for 2years.
Project team for treatment of refractory nephrotic syndromeThe Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, JapanComplete: follow-up complete16years-old75years-oldMale and Female100Not selectedJapan
264ChiCTR1900022518
2004-04-012019-04-15Clinical trial for corticosteroids monotherapy in the treatment of seronegative hepatitis B virus-associated membranous nephropathy.Efficacy and safety of corticosteroids in 26 cases of seronegative hepatitis B virus-associated membranous nephropathy Seronegative Hepatitis B Virus-associated Membranous NephropathyCase series:give corticosteroids(Methylprednisolone);Tianjin HospitalNULLCompletedBothCase series:26;China
265ChiCTR-TRC-09000539
2004-03-012009-09-30Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapyClinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy Nephrotic DiseaseS:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months;Second Hospital of Jilin UniversityNULLCompleted1669BothS:10;L:10;China
266NCT00404833
(ClinicalTrials.gov)
January 200327/11/2006Mycophenolate Mofetil in Membranous Nephropathy and Focal SegmentalA Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)Glomerulonephritis, Membranous;Glomerulosclerosis, FocalDrug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucilHospital Authority, Hong KongThe University of Hong KongCompleted18 Years65 YearsBoth16Phase 3China
267NCT00050713
(ClinicalTrials.gov)
December 17, 200217/12/2002Sirolimus Therapy for Idiopathic and Lupus Membranous NephropathySirolimus Therapy in Idiopathic and Lupus Membranous NephropathyMembranous Glomerulonephritis;Lupus Membranous NepropathyDrug: SirolimusNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted13 YearsN/AAll12Phase 2United States
268NCT00040508
(ClinicalTrials.gov)
June 200226/6/2002Sirolimus for Focal Segmental GlomerulosclerosisSirolimus for Focal Segmental GlomerulosclerosisFocal GlomerulosclerosisDrug: SirolimusNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/ABoth30Phase 2United States
269NCT00135967
(ClinicalTrials.gov)
May 200225/8/2005Mycophenolate Mofetil in Membranous NephropathyTreatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot StudyGlomerulonephritis, MembranousDrug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9Radboud UniversityHoffmann-La RocheCompleted18 Years75 YearsBoth30Phase 2/Phase 3Netherlands
270JPRN-C000000379
2001/04/0101/04/2006Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) Steroid-sensitive nephrotic syndromeprednisolone
mizoribine+prednisolone
Japanese Study Group of Renal Disease in Children(JSRDC)NULLComplete: follow-up complete1years-old10years-oldMale and Female50Not selectedJapan
271NCT00007475
(ClinicalTrials.gov)
December 200022/12/2000Permeability Factor in Focal Segmental GlomerulosclerosisPermeability Factor in Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisProcedure: Plasma exchange;Drug: CyclophosphamideNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/AAll15Phase 1/Phase 2United States
272NCT00004990
(ClinicalTrials.gov)
March 200018/3/2000Once-A-Month Steroid Treatment for Patients With Focal Segmental GlomerulosclerosisPulse Dexamethasone in Focal Segmental GlomerulosclerosisGlomerulonephritis;Nephrotic SyndromeDrug: DexamethasoneNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/ABoth20Phase 2United States
273NCT00001959
(ClinicalTrials.gov)
December 199918/1/2000Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)Pirfenidone in Focal Segmental Glomerulosclerosis:Phase II StudyFibrosis;Focal Glomerulosclerosis;Kidney Failure;Nephrotic Syndrome;ProteinuriaDrug: PirfenidoneNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 YearsN/AAll21Phase 2United States
274NCT00135954
(ClinicalTrials.gov)
July 199725/8/2005Treatment of Patients With Idiopathic Membranous NephropathyTreatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive TherapyGlomerulonephritis, MembranousDrug: Cyclophosphamide and steroidsRadboud UniversityNULLCompleted18 Years75 YearsBoth29Phase 3Netherlands
275EUCTR2021-000621-27-PL
(EUCTR)
01/09/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
276EUCTR2021-000621-27-NL
(EUCTR)
14/12/2021A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden
277EUCTR2020-003767-25-AT
(EUCTR)
20/10/2021A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
278EUCTR2016-003525-42-BE
(EUCTR)
30/10/2017A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Australia;Netherlands
279EUCTR2020-003767-25-BE
(EUCTR)
19/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
280EUCTR2021-000621-27-DE
(EUCTR)
08/09/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
281EUCTR2015-001039-18-Outside-EU/EEA
(EUCTR)
03/07/2015Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndromeOpen-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Astellas Pharma Korea, Inc.NULLNAFemale: yes
Male: yes
152Korea, Republic of
282EUCTR2020-003767-25-FR
(EUCTR)
29/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
283EUCTR2020-003767-25-CZ
(EUCTR)
15/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of
284EUCTR2015-005450-36-Outside-EU/EEA
(EUCTR)
01/08/2016Pilot to Evaluate the Safety and Efficacy of Abatacept in Adults and Children Over the Age of 6 With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change) Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb CompanyNULLNAFemale: yes
Male: yes
100Phase 2United States
285EUCTR2020-003767-25-DE
(EUCTR)
04/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of