66. IgA腎症 IgA nephropathy Clinical trials / Disease details


臨床試験数 : 255 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1NCT05174221
(ClinicalTrials.gov)
May 30, 202214/12/2021A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background TherapyA Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background TherapyKidney DiseaseDrug: MezagitamabTakedaNULLNot yet recruiting18 YearsN/AAll16Phase 1NULL
2NCT05125068
(ClinicalTrials.gov)
February 28, 20228/11/2021Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA NephropathyIgA Nephropathy;IgANDrug: AT-1501Eledon PharmaceuticalsNULLNot yet recruiting18 Years99 YearsAll42Phase 2NULL
3NCT05083364
(ClinicalTrials.gov)
February 2, 20228/10/2021Study of ARO-C3 in Adult Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria and Complement-Mediated Renal DiseaseA Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Adult Patients With Complement-Mediated Renal DiseaseParoxysmal Nocturnal Hemoglobinuria;C3 Glomerulopathy;IgA NephropathyDrug: ARO-C3;Drug: PlaceboArrowhead PharmaceuticalsNULLRecruiting18 Years70 YearsAll62Phase 1New Zealand
4EUCTR2020-002200-40-DK
(EUCTR)
11/01/202202/07/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
5EUCTR2021-000621-27-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
6EUCTR2020-003084-26-CZ
(EUCTR)
24/11/202113/07/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);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
320Phase 3United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
7EUCTR2020-004892-41-DE
(EUCTR)
16/11/202109/06/2021Atacicept in Subjects with IgA Nephropathy (ORIGIN)A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Vera Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Belarus;United States;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Malaysia;Belgium;Poland;Australia;Germany;Korea, Republic of
8NCT04905212
(ClinicalTrials.gov)
November 4, 202121/5/2021A Study of Telitacicept for Injection (RC18) in Subjects With IgA NephropathyA Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA NephropathyIgA NephropathyDrug: Telitacicept 160mg;Drug: Telitacicept 240mg;Drug: PlaceboRemeGen Co., Ltd.NULLRecruiting18 Years70 YearsAll30Phase 2United States
9EUCTR2020-002200-40-NO
(EUCTR)
14/10/202126/08/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden;United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France
10EUCTR2018-000075-33-GR
(EUCTR)
13/10/202113/07/2021OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Greece;Thailand;Spain;Italy;Australia;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
11EUCTR2020-005855-19-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
12EUCTR2021-000621-27-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
13EUCTR2020-005855-19-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
14NCT04557462
(ClinicalTrials.gov)
September 20, 202115/9/2020A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA NephropathyA Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301Primary IgA NephropathyDrug: LNP023Novartis PharmaceuticalsNULLRecruiting18 YearsN/AAll410Phase 3Belgium;Germany
15EUCTR2020-002200-40-NL
(EUCTR)
14/09/202123/07/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
16NCT05016323
(ClinicalTrials.gov)
September 9, 202117/8/2021A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.IgA NephropathyDrug: HR19042 Capsules;Drug: PlaceboJiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 YearsN/AAll210Phase 2China
17EUCTR2020-004892-41-GR
(EUCTR)
06/09/202119/07/2021Atacicept in Subjects with IgA Nephropathy (ORIGIN)A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
Product Code: VT-001
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Vera Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2United States;Belarus;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Belgium;Malaysia;Poland;Australia;Germany;Korea, Republic of
18NCT05065970
(ClinicalTrials.gov)
August 31, 202114/9/2021Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA NephropathyImmunoglobulin A (IgA) NephropathyDrug: Felzartamab;Other: PlaceboMorphoSys AGNULLRecruiting18 Years80 YearsAll48Phase 2United States;Australia;Belgium;Bulgaria;Germany;Korea, Republic of;Malaysia;Serbia;Spain;Ukraine;United Kingdom
19EUCTR2020-005054-19-DE
(EUCTR)
16/08/202101/04/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
20EUCTR2020-002200-40-DE
(EUCTR)
05/08/202124/06/2021A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathyA multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
427Phase 3United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
21EUCTR2020-005054-19-CZ
(EUCTR)
28/07/202109/03/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
22EUCTR2020-003084-26-PL
(EUCTR)
13/07/202128/01/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);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
320Phase 3United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
23EUCTR2020-005054-19-ES
(EUCTR)
08/07/202109/07/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 23.1;Level: PT;Classification code 10084204;Term: Sickle cell nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
24NCT04887532
(ClinicalTrials.gov)
July 1, 202113/5/2021A Trial of HR19042 Capsule in Healthy Chinese SubjectsSafety and Pharmacokinetics of HR19042 Capsule After Single Administration in Healthy Chinese SubjectsPrimary IgA NephropathyDrug: HR19042 capsuleJiangsu HengRui Medicine Co., Ltd.NULLCompleted18 Years45 YearsAll12Phase 1China
25EUCTR2020-005054-19-BE
(EUCTR)
30/06/202107/05/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Serbia;Philippines;Czechia;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of
26EUCTR2020-005054-19-BG
(EUCTR)
30/06/202118/03/2021A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA NephropathyA Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ IgA Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Felzartamab
Product Code: MOR202
INN or Proposed INN: Felzartamab
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2United States;Serbia;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
27EUCTR2020-001537-13-DE
(EUCTR)
30/06/202129/01/2021Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;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;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: BNJ441
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of
28EUCTR2020-003084-26-IT
(EUCTR)
08/06/202108/06/2021A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - ALIGN Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Atrasentan
Product Code: [Atrasentan]
INN or Proposed INN: Atrasentan
CHINOOK THERAPEUTICS, U.S., IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 3United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
29JPRN-jRCT2071210028
01/06/202125/05/2021The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal functionA Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function - The ALIGN Study IgA Nephropathy at Risk of Progressive Loss of Renal FunctionDrug: Atrasentan
Film-coated tablet
Other Names:
CHK-01
Atrasentan Hydrochloride
ABT-627
Drug: Placebo
Film-coated tablet
Yamada ShujiNULLPending>= 18age oldNot applicableBoth24Phase 3Argentina;Australia;Brazil;Canada;China;Colombia;Czech Republic;France;Germany;Hong Kong;India;Italy;New Zealand;Poland;South Korea;Spain;Taiwan;United Kingdom;United States;Japan
30NCT04833374
(ClinicalTrials.gov)
May 24, 20214/4/2021Steroids Therapy in IgA Nephropathy With CrescentsEffect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.IgA NephropathyDrug: MethylprednisoloneSixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting14 Years65 YearsAll200Phase 3China
31EUCTR2020-001537-13-IT
(EUCTR)
19/05/202108/06/2021Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN Lupus Nephritis (LN) - Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;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;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
INN or Proposed INN: Ravulizumab
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Taiwan;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden
32NCT04716231
(ClinicalTrials.gov)
May 18, 202111/1/2021Atacicept in Subjects With IgA NephropathyA Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN)IgA Nephropathy;Berger DiseaseBiological: Atacicept;Other: Placebo to match AtaciceptVera Therapeutics, Inc.NULLRecruiting18 YearsN/AAll105Phase 2United States;Australia;Belgium;Czechia;Germany;Greece;India;Korea, Republic of;Malaysia;Turkey;United Kingdom
33EUCTR2020-001049-38-CZ
(EUCTR)
13/05/202102/02/2021Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
34EUCTR2020-001049-38-NL
(EUCTR)
04/05/202117/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
35EUCTR2020-001537-13-ES
(EUCTR)
29/04/202109/02/2021Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;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;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: BNJ441
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of
36EUCTR2020-001537-13-SE
(EUCTR)
23/04/202129/01/2021Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;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;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: BNJ441
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of
37ChiCTR2100045306
2021-04-102021-04-10A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathyA multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy IgA nephropathyHydroxychloroquine group:Hydroxychloroquine and Kunxian capsule placebo;Kunxian capsule group:Kunxian capsule and Hydroxychloroquine placebo;Placebo group:Kunxian capsule and Hydroxychloroquine placebo;Peking University First HospitalNULLRecruiting18BothHydroxychloroquine group:65;Kunxian capsule group:65;Placebo group:65;China
38EUCTR2020-003084-26-DE
(EUCTR)
08/04/202121/12/2020A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study Immunoglobulin A Nephropathy (IgAN);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
320Phase 3United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
39ChiCTR2100052910
2021-04-012021-11-06To investigate the efficacy and safety of hydroxychloroquine in IgA nephropathy based on PPK modelEfficacy and safety evaluation of hydroxychloroquine in the treatment of IgA nephropathy IgA nephropathyExperimental group:RAASi + hydroxychloroquine ;Cotrol group :RAASi+placebo ;Department of Pharmacy, Drum Tower Hospital Affiliated to Nanjing University Medical SchoolNULLRecruiting1875BothExperimental group:50;Cotrol group :50;Phase 1China
40EUCTR2020-001049-38-NO
(EUCTR)
16/03/202119/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
41ChiCTR2100042331
2021-03-012021-01-19Effect evaluation and related mechanism research on different stages of IgA nephropathy treated by supplementing Qi, nourishing Yin and removing blood stasisEffect evaluation and related mechanism research on different stages of IgA nephropathy treated by supplementing Qi, nourishing Yin and removing blood stasis IgANtreatment group:Add or subtract Shenqi Dihuang soup;treatment group:Remove blood stasis and remove cloudy drink;matched group:Nil;matched group:Nil;Zhejiang Provincal Hospital of Traditional Chinese MedicineNULLRecruiting1875Bothtreatment group:35;treatment group:60;matched group:35;matched group:60;China
42EUCTR2020-001049-38-IT
(EUCTR)
24/02/202120/05/2021Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallelgroup, phase III study to evaluate the efficacy and safety of LNP023 inprimary IgA nephropathy patients - Study of efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ACTHIB - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE+1 SIRINGA PRERIEMPITA SOLVENTE 0.5 ML
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: MENVEO - POLV.E SOLUZ.PER SOLUZ. INIETT.-USO INTRAMUSCOLARE-COMP. CONIUG.LIOFILIZZ.MENA:FLAC.(VETRO) COMP. GONIUG.LIQUI.MENCWY:FLAC.(VETRO)-1 FLAC+1FLAC
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO PNEUMOCOCCICO
Trade Name: BEXSERO - SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA PRERIEMPITA (VETRO) - 0.5ML - 1 SIRINGA PRERIEMPITA CON AGO
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B
Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML
Product Name: -
Product Code: [-]
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
43EUCTR2020-001049-38-SE
(EUCTR)
23/02/202102/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
44EUCTR2020-003308-14-FI
(EUCTR)
22/02/202127/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
45EUCTR2020-001049-38-BE
(EUCTR)
17/02/202117/02/2021Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
46NCT04573920
(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
47NCT04578834
(ClinicalTrials.gov)
January 25, 20219/9/2020Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsIgA NephropathyDrug: Placebo;Drug: LNP023Novartis PharmaceuticalsNULLRecruiting18 YearsN/AAll450Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Russian Federation;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Vietnam
48EUCTR2020-001049-38-FR
(EUCTR)
13/01/202102/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
49EUCTR2020-001049-38-DK
(EUCTR)
07/01/202111/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
50EUCTR2020-001049-38-FI
(EUCTR)
31/12/202010/12/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
51EUCTR2020-001049-38-DE
(EUCTR)
17/12/202006/11/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden
52EUCTR2020-001049-38-HU
(EUCTR)
17/12/202027/10/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
53NCT04573478
(ClinicalTrials.gov)
December 11, 202012/9/2020Atrasentan in Patients With IgA NephropathyA Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal FunctionIgA Nephropathy;Immunoglobulin A NephropathyDrug: Atrasentan;Drug: PlaceboChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll320Phase 3United States;Australia;Brazil;Canada;France;Germany;Hong Kong;Italy;Japan;Korea, Republic of;New Zealand;Poland;Spain;Taiwan
54EUCTR2020-003308-14-GR
(EUCTR)
03/12/202026/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
55EUCTR2020-003308-14-PL
(EUCTR)
24/11/202001/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
56ChiCTR2000040161
2020-11-152020-11-23Study on dose-effect relationship and safety of Modified Huangqi Chifeng Decoction with different doses of Astragalus in the treatment of IgA nephroproteinuriaStudy on dose-effect relationship and safety of Modified Huangqi Chifeng Decoction with different doses of Astragalus in the treatment of IgA nephroproteinuria IgA nephropathycontrol group:Placebo + telmisartan tablet;Experimental group 1:Modified Huangqi Chifeng Decoction 1 + telmisartan tablet;Experimental group 2:Modified Huangqi Chifeng Decoction 2 + telmisartan tablet;Experimental group 3:Modified Huangqi Chifeng Decoction 3 + telmisartan tablet;Xiyuan Hospital, China Academy of Chinese Medical SciencesNULLPendingBothcontrol group:30;Experimental group 1:30;Experimental group 2:30;Experimental group 3:30;N/AChina
57NCT04541043
(ClinicalTrials.gov)
November 14, 20201/9/2020Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301Primary IgA NephropathyDrug: NefeconCalliditas Therapeutics ABNULLRecruiting18 YearsN/AAll250Phase 3Sweden
58EUCTR2020-003308-14-FR
(EUCTR)
13/11/202013/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
59EUCTR2020-003308-14-GB
(EUCTR)
12/11/202021/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
60EUCTR2020-003308-14-IT
(EUCTR)
12/11/202024/05/2021Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 - - Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: [Nefecon]
INN or Proposed INN: BUDESONIDE
CALLIDITAS THERAPEUTICS ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
61EUCTR2020-003308-14-CZ
(EUCTR)
21/10/202016/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
62EUCTR2020-003308-14-SE
(EUCTR)
21/10/202018/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Korea, Republic of;Sweden;Germany;Australia;Belgium;Poland;Argentina;Canada;Czech Republic;France;Italy;United Kingdom;Turkey;Spain;Finland;Greece;Taiwan;Belarus;United States
63NCT04438603
(ClinicalTrials.gov)
October 1, 202017/6/2020The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA NephropathyThe Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA NephropathyIgA NephropathyDrug: Intervention for incipient patients at low risk of disease progression;Drug: Intervention for patients at high risk of disease progressionXinhua Hospital, Shanghai Jiao Tong University School of MedicineRenJi Hospital;Shanghai Zhongshan Hospital;Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting18 Years80 YearsAll180China
64ChiCTR2000038104
2020-09-012020-09-10Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial.Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial. IgA nephropathyGroup 1:Artesunate 100mg (50mg/Bid);Group 2:Artesunate 50mg (25mg/Bid);The control group:Placebo;Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese MedicineNULLRecruitingBothGroup 1:40;Group 2:40;The control group:40;China
65ChiCTR2000036468
2020-08-252020-08-23A Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA NephropathyA Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA Nephropathy IgANRituximab group:Rituximab+RASi;control group:RASi;Ruijin Hospital, Shanghai Jiaotong University School of MedicineNULLRecruiting1875BothRituximab group:58;control group:58;Phase 4China
66NCT04287985
(ClinicalTrials.gov)
July 20, 202010/2/2020Safety and Efficacy Study of VIS649 for IgA NephropathyA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) NephropathyImmunoglobulin A Nephropathy;Glomerular Disease;IgANDrug: Dose-Placebo;Drug: Low Dose-VIS649;Drug: Medium Dose-VIS649;Drug: High Dose-VIS649Visterra, Inc.NULLRecruiting18 YearsN/AAll144Phase 2United States;Australia;Canada;Hong Kong;India;Japan;Korea, Republic of;Malaysia;Philippines;Singapore;Spain;Sri Lanka;Taiwan;Thailand;United Kingdom
67NCT04525729
(ClinicalTrials.gov)
July 1, 202017/8/2020Rituximab and RASi in Patients With IgANA Multicentre, Randomized, Controlled Study of Rituximab in Treatment of Primary IgA NephropathyIgA NephropathyDrug: Rituximab;Drug: RAS 2410CHENNANDongfang Hospital Affiliated to Tongji University;Shanghai Pudong New Area People's Hospital;Ruijin Hospital North Shanghai Jiao Tong University School of Medicine;Ningbo Municipal Yinzhou District No.2 Hospital;Third Affiliated Hospital, Sun Yat-Sen University;Xiamen Hongai Hospital;Sir Run Run Shaw HospitalRecruiting18 Years75 YearsAll116Phase 4China
68NCT04342325
(ClinicalTrials.gov)
June 15, 20208/4/2020The Clinical Trial of ADR-001 for IgA NephropathyOpen-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) NephropathyGlomerulonephritis , IGABiological: infusion of ADR-001 (Mesenchymal stem cell)Nagoya UniversityRohto Pharmaceutical Co., Ltd.Active, not recruiting20 YearsN/AAll9Phase 1Japan
69NCT04291781
(ClinicalTrials.gov)
April 13, 202027/2/2020A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) NephropathyPhase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of IgA NephropathyIgA NephropathyBiological: RC18 160mg;Biological: RC18 240mg;Biological: placeboRemeGen Co., Ltd.NULLCompleted18 Years70 YearsAll44Phase 2China
70EUCTR2019-002531-29-GB
(EUCTR)
24/03/202017/12/2019A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy Immunoglobulin A (IgA) Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Visterra, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Philippines;Hong Kong;Taiwan;Thailand;Spain;United Kingdom;India;Czech Republic;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of
71EUCTR2018-000075-33-DE
(EUCTR)
19/12/201901/07/2019OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
72EUCTR2017-000891-27-IT
(EUCTR)
18/12/201930/09/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
73EUCTR2018-002012-27-GB
(EUCTR)
09/12/201908/10/2019Testing the Safety and Activity of Sparsentan in the Treatment of Patients with IgA NephropathyA Single Centre, Open-label, Single-group Exploratory Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients with Immunoglobulin A Nephropathy - SPARTAN v1.0 Immunoglobulin A (IgA) nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
University of LeicesterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2United Kingdom
74NCT04014335
(ClinicalTrials.gov)
December 4, 20198/7/2019A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA NephropathyAn Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA NephropathyPrimary IgA NephropathyDrug: IONIS-FB-LRxIonis Pharmaceuticals, Inc.NULLRecruiting18 Years75 YearsAll10Phase 2Australia;Canada;New Zealand
75ChiCTR1900026883
2019-12-012019-10-25A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathyA prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy IgA nephropathy1:0.5mg/kg.d prednisolone induced remission;2:0.8mg/kg.d prednisolone induced remission ;Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang ProvinceNULLPending1872Both1:71;2:71;China
76NCT04042623
(ClinicalTrials.gov)
November 27, 201931/7/2019Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA NephropathyAn Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA NephropathyIgA NephropathyDrug: AVB-S6-500Aravive, Inc.NULLTerminated18 YearsN/AAll1Phase 2United States
77EUCTR2018-000075-33-GB
(EUCTR)
06/11/201927/06/2019OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
78EUCTR2017-000891-27-FR
(EUCTR)
29/10/201912/08/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;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
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
79EUCTR2017-000891-27-CZ
(EUCTR)
10/10/201903/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
80EUCTR2018-000075-33-IT
(EUCTR)
26/09/201918/06/2021OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.0;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]
Product Name: OMS721
Product Code: [OMS721]
INN or Proposed INN: OMS721
OMEROS CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden
81EUCTR2017-000891-27-HU
(EUCTR)
25/09/201930/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;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
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore
82NCT04020328
(ClinicalTrials.gov)
September 12, 201910/7/2019Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal InsufficiencyA Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal InsufficiencyGlomerulonephritis, IGA;Renal Insufficiency, ChronicDrug: Leflunomide 20 mg+prednisone 0.5mg/kg/dShenzhen Second People's HospitalNULLRecruiting14 Years65 YearsAll70Phase 4China
83EUCTR2017-004605-41-DE
(EUCTR)
20/07/201925/06/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Overencapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (ANDA 203071)
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
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 (NDA 020 757)
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
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
84NCT03418779
(ClinicalTrials.gov)
July 4, 201911/1/2018Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRDTreatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)IgA Nephropathy at High Risk of Developing ESRDDrug: The Yi-Qi-Qing-Jie herbal compound;Drug: Immunosuppressants;Other: Optimized Supportive Care;Other: Yi-Qi-Qing-Jie herbal compound placeboGuang'anmen Hospital of China Academy of Chinese Medical SciencesChina Academy of Chinese Medical SciencesRecruiting18 Years70 YearsAll60Phase 2/Phase 3China
85EUCTR2018-002716-27-GB
(EUCTR)
11/06/201907/01/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Other descriptive name: CEMDISIRAN
Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden
86EUCTR2018-002716-27-SE
(EUCTR)
28/05/201906/02/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Other descriptive name: CEMDISIRAN
Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2France;United States;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden
87EUCTR2017-004366-10-GB
(EUCTR)
24/05/201904/02/2019Efficacy and Safety of Belimumab in the Treatment of IgA NephropathyA Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy Immunoglobulin A (IgA) nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA® (belimumab)
Product Name: BENLYSTA® (belimumab)
Product Code: GSK1550188
INN or Proposed INN: Belimumab
Other descriptive name: GSK1550188; Benlysta
University of LeicesterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
21 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
88NCT03841448
(ClinicalTrials.gov)
April 24, 201913/2/2019A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA NephropathyIgA Nephropathy (IgAN);Berger Disease;Glomerulonephritis, IgADrug: Placebo;Drug: CemdisiranAlnylam PharmaceuticalsNULLActive, not recruiting18 Years65 YearsAll31Phase 2Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom;United States
89EUCTR2018-002716-27-ES
(EUCTR)
08/04/201912/04/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Other descriptive name: CEMDISIRAN
Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of
90NCT03945318
(ClinicalTrials.gov)
April 8, 201921/4/2019Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA NephropathyIgA NephropathyDrug: BION-1301 Single Dose;Drug: Placebo Single Dose;Drug: BION-1301 Multiple Doses;Drug: Placebo Multiple DosesChinook Therapeutics, Inc.NULLRecruiting18 YearsN/AAll112Phase 1/Phase 2United States;United Kingdom
91ChiCTR1900022100
2019-04-012019-03-25Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin”Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin” IgA nephropathyPlacebo Group:Placebo+telmisartan;Experimental group:Flavoured huangqi chifeng granules+telmisartan;Xiyuan Hospital, China Academy of Chinese Medical SciencesNULLRecruitingBothPlacebo Group:40;Experimental group:40;N/AChina
92NCT03468972
(ClinicalTrials.gov)
March 201912/3/2018Effect of Immunosuppression in IgA NephropathyEffect of Immunosuppression in IgA NephropathyBiopsy-proven IgA NephropathyDrug: Immunosuppressive treatment;Other: intensive supportive careYonsei UniversityNULLNot yet recruiting19 Years75 YearsAll174Phase 4Korea, Republic of
93EUCTR2017-004605-41-PT
(EUCTR)
04/02/201924/08/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/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
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
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
94EUCTR2017-004605-41-PL
(EUCTR)
17/01/201905/11/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/over-encapsulated Spasenten 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
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
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
95NCT03762850
(ClinicalTrials.gov)
December 20, 201827/11/2018A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA NephropathyA Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A NephropathyImmunoglobulin A NephropathyDrug: sparsentan;Drug: irbesartanTravere Therapeutics, Inc.NULLActive, not recruiting18 YearsN/AAll380Phase 3United States;Australia;Belgium;Croatia;Czechia;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;Lithuania;New Zealand;Poland;Portugal;Spain;Taiwan;United Kingdom
96ChiCTR1800019606
2018-12-012018-11-19Effect of kunxian capsule and leflunomide on IgA nephropathyEffect of kunxian capsule and leflunomide on IgA nephropathy IgA nephropathy1:Kun-Xian Capsule;2:Leflunomide;The First Affiliated Hospital of Chengdu Medical CollegeNULLPending1575Both1:20;2:20;China
97EUCTR2017-004605-41-HR
(EUCTR)
23/11/201816/05/2019Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: 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
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
98EUCTR2017-004902-16-IT
(EUCTR)
16/11/201820/01/2021A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primar Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: [Nefecon]
INN or Proposed INN: BUDESONIDE
CALLIDITAS THERAPEUTICS ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
99EUCTR2018-000075-33-AT
(EUCTR)
15/11/201825/06/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of
100EUCTR2017-004605-41-IT
(EUCTR)
25/10/201828/01/2021Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan compresse
Product Code: [RE-021]
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
Product Code: C09
Trade Name: SMOFKABIVEN - EMULSIONE PER INFUSIONE SENZA ELETTROLITI 1 SACCA BIOFINE MULTICOMPARTIMENTATE DA 493 ML
Product Name: over-encapsulated Irbesartan Tablets
Product Code: [000000000]
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
RETROPHIN, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
101NCT03719443
(ClinicalTrials.gov)
October 9, 201810/10/2018First in Human Study to Assess Safety of VIS649 in Healthy SubjectsA Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy SubjectsImmunoglobulin A Nephropathy;IgAN - IgA Nephropathy;IgA NephropathyBiological: VIS649;Biological: PlaceboVisterra, Inc.NULLCompleted18 Years55 YearsAll41Phase 1United States
102EUCTR2017-004605-41-GB
(EUCTR)
04/10/201804/06/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - 021IGAN17001 (PROTECT) Sparsentan in IGAN Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/Overencapsulated Sparsentan tablets
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: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
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
380Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
103EUCTR2017-004605-41-CZ
(EUCTR)
03/10/201817/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/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
Travere Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
104EUCTR2018-000075-33-BE
(EUCTR)
03/10/201831/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
105EUCTR2017-004605-41-BE
(EUCTR)
28/09/201806/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/ 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
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
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
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
106EUCTR2017-004605-41-ES
(EUCTR)
27/09/201830/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;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 150 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Estonia;Hong Kong;Spain;Lithuania;Turkey;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Malaysia;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
107EUCTR2018-000075-33-PL
(EUCTR)
17/09/201810/07/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
108EUCTR2018-000075-33-CZ
(EUCTR)
06/09/201806/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
109EUCTR2018-000075-33-BG
(EUCTR)
05/09/201819/07/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
110NCT03643965
(ClinicalTrials.gov)
September 5, 20188/8/2018A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)Primary IgA NephropathyDrug: Nefecon;Drug: Placebo oral capsuleCalliditas Therapeutics ABNULLActive, not recruiting18 YearsN/AAll365Phase 3United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom
111EUCTR2017-004605-41-EE
(EUCTR)
05/09/201831/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/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
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
380Phase 3United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
112EUCTR2018-000075-33-SE
(EUCTR)
03/09/201803/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;China;Sweden;Korea, Republic of
113EUCTR2017-004902-16-PL
(EUCTR)
27/08/201818/07/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada
114EUCTR2017-004605-41-LT
(EUCTR)
23/08/201802/07/2018Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan tablets/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
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
380Phase 3Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
115EUCTR2018-000075-33-ES
(EUCTR)
01/08/201821/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
434Phase 3United States;Slovakia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Sweden
116EUCTR2017-004902-16-FI
(EUCTR)
18/07/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
117EUCTR2018-000075-33-SK
(EUCTR)
21/06/201820/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
118EUCTR2017-004902-16-BE
(EUCTR)
18/06/201821/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
119EUCTR2018-000075-33-LT
(EUCTR)
15/06/201823/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Narsoplimab
Product Code: OMS721
INN or Proposed INN: Narsoplimab
Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
120EUCTR2018-000075-33-HU
(EUCTR)
07/06/201829/03/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
434Phase 3United States;Hungary;Canada;Australia
121EUCTR2017-004902-16-CZ
(EUCTR)
04/06/201812/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
122EUCTR2017-004902-16-GB
(EUCTR)
29/05/201822/06/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
123EUCTR2017-000891-27-DK
(EUCTR)
25/05/201811/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
124EUCTR2017-000891-27-NL
(EUCTR)
25/05/201809/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
125EUCTR2017-000891-27-BE
(EUCTR)
22/05/201819/03/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;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
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
126EUCTR2017-004902-16-ES
(EUCTR)
09/04/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden
127EUCTR2017-000891-27-DE
(EUCTR)
06/04/201824/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Belgium;Singapore;Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil
128JPRN-UMIN000032031
2018/04/0101/04/2018The steroid internal use method for patients with IgA nephropathyThe steroid internal use method for patients with IgA nephropathy - The steroid internal use method for patients with IgA nephropathy IgA nephropathyPrednisolone 0.5mg/kg/every other day group
Prednisolone 0.25mg/kg/everyday group
Juntendo UniversityNULLRecruiting20years-old100years-oldMale and Female100Not selectedJapan
129EUCTR2017-004902-16-SE
(EUCTR)
28/03/201813/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
130NCT03188887
(ClinicalTrials.gov)
February 20, 20182/5/2017Treatment of IgA Nephropathy According to Renal LesionsTreatment of IgA Nephropathy According to Renal LesionsIgA NephropathyDrug: corticotherapy;Drug: Renin Angiotensin system (RAS) blockadeAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll122Phase 3France
131EUCTR2017-000891-27-SE
(EUCTR)
19/02/201817/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden;Hungary;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;Jordan;France;India;Italy;Colombia;Israel;Lebanon;Spain;Thailand;Hong Kong;Taiwan;Philippines;United States
132NCT03608033
(ClinicalTrials.gov)
February 16, 201821/6/2018Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) NephropathyA Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)IgA NephropathyBiological: OMS721;Other: Vehicle (D5W or saline)Omeros CorporationNULLRecruiting18 YearsN/AAll450Phase 3United States;Australia;Austria;Belgium;Bulgaria;Hungary;Lithuania;Poland;Slovakia;Spain
133NCT03373461
(ClinicalTrials.gov)
February 7, 201830/11/2017Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by InflammationAn Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsIgA NephropathyDrug: LNP023;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll112Phase 2Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;India;Israel;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Hungary;Italy;Spain;United States
134NCT03453619
(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
135EUCTR2017-000891-27-FI
(EUCTR)
09/01/201823/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
136ChiCTR-IIR-17013487
2018-01-012017-11-22A multicenter, double blind, double dummy, randomized controlled clinical study on the treatment of IgA nephropathy with Zhengqingfengtongning extantabA multicenter, double blind, double dummy, randomized controlled clinical study on the treatment of IgA nephropathy with Zhengqingfengtongning extantab IgA nephropathyExperimental group:Zhengqing Fengtongning extantab;Control group 1:Losartan Potassium Tablets;Control group 2:Losartan Potassium Tablets + Zhengqing Fengtongning extantab;The Third Xiangya Hospital of Central South UniversityNULLRecruiting1870BothExperimental group:36;Control group 1:36;Control group 2:36;4 (Phase 4 study)China
137NCT03366337
(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
138NCT03633864
(ClinicalTrials.gov)
November 22, 20177/8/2018Fecal Microbiota Transplantation for Refractory IgA NephropathyFecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort StudyIgA NephropathyBiological: Fecal microbiota transplantationAir Force Military Medical University, ChinaNULLUnknown status18 Years65 YearsAll30Phase 2China
139EUCTR2017-000891-27-GB
(EUCTR)
21/11/201706/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
140EUCTR2016-002262-31-GB
(EUCTR)
17/03/201727/01/2017A Clinical Trial to Examine the Effects of the Drug Atacicept in Patients with Nephropathy (Diabetic Kidney Disease).A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy IgA Nephropathy
MedDRA version: 20.1;Level: PT;Classification code 10061835;Term: Diabetic nephropathy;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;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of
141JPRN-JapicCTI-183956
21/2/201714/05/2018A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy IgA NephropathyIntervention name : Atacicept25mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 25 milligram (mg) once weekly as a subcutaneous (SC) injection for 72 weeks.
Intervention name : Atacicept75mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 72 weeks.
Intervention name : Atacicept25mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 25 mg once weekly as an SC injection for 156 weeks.
Intervention name : Atacicept75mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 156 weeks.
Intervention name : Atacicept150mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 150 mg once weekly as an SC injection for 156 weeks.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 72 weeks.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 156 weeks.
Merck Biopharma Co., Ltd.NULLcomplete20BOTH60Phase 2Japan, Europe
142NCT02808429
(ClinicalTrials.gov)
January 31, 201716/6/2016Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyIgA NephropathyDrug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mgEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 YearsN/AAll16Phase 2United States;Japan;United Kingdom;Germany
143EUCTR2016-004507-31-FR
(EUCTR)
27/01/201702/02/2017N/AN/A - TIGER
MedDRA version: 19.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Trade Name: METHYLPREDNISOLONE MYLAN Générique
Product Name: METHYLPREDNISOLONE MYLAN Générique
INN or Proposed INN: Methylprednisolone
Other descriptive name: Methylprednisolone
Trade Name: PREDNISONE ARROW 20mg
Product Name: PREDNISONE ARROW 20mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: PREDNISONE ARROW 5 mg
Product Name: PREDNISONE ARROW 5 mg
INN or Proposed INN: Prednisone 5 mg
Other descriptive name: Prednisone 5 mg
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
122Phase 3France
144ChiCTR-IOR-16010174
2016-12-012016-12-16Clinical Study on Treatment of spleen and kidney Yang deficiency type of IgA nephropathy proteinuria with 'Huangqi guizhi wuwu' decoctionClinical Study on Treatment of spleen and kidney Yang deficiency type of IgA nephropathy proteinuria with 'Huangqi guizhi wuwu' decoction IgA nephropathyBasic treatment+Valsartan Capsules treatment group:Basic treatment+Valsartan Capsules treatment ;Basic treatment+Huangqi guizhi wuwu decoction treatment group:Basic treatment+Huangqi guizhi wuwu decoction treatment;Shuguang Hospital affliliated to Shanghai Univesrity of TCMNULLRecruiting1865BothBasic treatment+Valsartan Capsules treatment group:50;Basic treatment+Huangqi guizhi wuwu decoction treatment group:50;China
145NCT03218852
(ClinicalTrials.gov)
December 20167/12/2016Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyAn Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA NephropathyIgA NephropathyDrug: prednisone and cyclophosphamide;Drug: prednisone aloneGuangdong General HospitalNULLActive, not recruiting18 Years70 YearsAll133Phase 4China
146NCT02942381
(ClinicalTrials.gov)
September 13, 201614/10/2016A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA NephropathyIgA Patients;HydroxychloroquineDrug: Hydroxychloroquine Sulfate;Drug: PlaceboPeking University First HospitalNULLCompleted18 Years75 YearsAll60Phase 2China
147NCT02981212
(ClinicalTrials.gov)
June 201624/11/2016Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA NephropathyMulti-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA NephropathyIgA NephropathyDrug: Mycophenolate Mofetil;Drug: ACE inhibitor;Drug: Corticosteroid;Drug: ARBYonsei UniversityChong Kun Dang Pharmaceutical Corp.;Kyung Hee University Hospital at Gangdong;Kyungpook National University;Pusan National University Yangsan Hospital;Inje University;Seoul St. Mary's Hospital;Chonbuk National University HospitalRecruiting19 Years65 YearsBoth100Phase 4Korea, Republic of
148NCT02765594
(ClinicalTrials.gov)
June 201630/4/2016Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA NephropathyHydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled StudyPrimary IgA NephropathyDrug: Hydroxychloroquine Sulfate;Drug: ValsartanPeking Union Medical College HospitalNULLRecruiting18 Years60 YearsAll98Phase 4China
149NCT02712697
(ClinicalTrials.gov)
June 201617/11/2015Integrative Medicine of IgA NephropathyTreatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical TrialPrimary IgA NephropathyDrug: WM (Shentong Granules);Drug: Hormone (prednisone)Shanghai University of Traditional Chinese MedicineRenJi Hospital;Ruijin Hospital;Shanghai 6th People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Fudan UniversityNot yet recruiting18 Years70 YearsBoth140N/AChina
150NCT02662283
(ClinicalTrials.gov)
May 201620/1/2016Validity and Security of Reh-acteoside Therapy for Patients of IgA NephropathyValidity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical TrialIGA NephropathyDrug: Prednisolone;Drug: Reh-acteosideSun Yat-sen UniversityNULLNot yet recruiting14 Years70 YearsBoth75Phase 2/Phase 3China
151NCT02647255
(ClinicalTrials.gov)
March 201621/12/2015Trial of Plasma Exchange for Severe Crescentic IgA NephropathyRandomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study)Glomerulonephritis, IGA;Kidney Diseases;Acute Renal Insufficiency;Rapidly Progressive GlomerulonephritisProcedure: Plasma Exchange (PE);Drug: Methylprednisolone pulsePeking University First HospitalNULLTerminated14 Years65 YearsAll10Phase 2/Phase 3China
152NCT02682407
(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
153NCT03015974
(ClinicalTrials.gov)
January 20163/1/2017Registry of IgA Nephropathy in Chinese ChildrenRegistry of IgA Nephropathy in Chinese ChildrenIgA Nephropathy;Proteinuria in Nephrotic Range;Immunosuppressive TreatmentDrug: Corticosteroid;Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Dipyridamole;Drug: ACE Inhibitor or Angiotensin receptor antagonistPeking University First HospitalNanjing PLA General Hospital;Beijing Children's Hospital;Central South University;The Children's Hospital of Zhejiang University School of Medicine;First Affiliated Hospital, Sun Yat-Sen University;Tongji Hospital;Hunan Children's Hospital;Shanghai Children's Hospital;Nanjing Children's Hospital;Children's Hospital of Chongqing Medical University;Shandong Provincial Hospital;Fuzhou General Hospital;Second Affiliated Hospital of Wenzhou Medical University;Children's Hospital of Hebei Province;Guangzhou Women and Children's Medical Center;Jiangxi Province Children's Hospital;Guangzhou First People's Hospital;Xian Children's Hospital;Capital Institute of Pediatrics, China;First Hospital of Jilin University;Wuhan Women and Children's Medical Center;Tianjin Children's Hospital;Chengdu Women's and Children's Central Hospital;The First People's Hospital of YunnanRecruiting1 Month18 YearsAll1200China
154NCT02605525
(ClinicalTrials.gov)
December 31, 201512/11/2015Efficacy and Safety of SM101 in the Treatment of IgA NephropathyA Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)Immunoglobulin A NephropathyBiological: SM101;Other: PlaceboBaxalta now part of ShireNULLWithdrawn18 YearsN/AAll0Phase 2NULL
155EUCTR2015-002345-64-CZ
(EUCTR)
12/11/201508/09/2015Efficacy and Safety of SM101 in the Treatment of IgA NephropathyA Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy IgA Nephropathy
MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: SM101
INN or Proposed INN: Not available
Other descriptive name: human soluble recombinant Fc-gamma receptor IIB
Baxalta Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
51Phase 2United States;Hong Kong;Czech Republic;Canada;Belgium;Denmark;Germany;United Kingdom;Sweden
156NCT02433236
(ClinicalTrials.gov)
September 201529/4/2015Open Label Study of Fostamatinib in the Treatment of IgA NephropathyA Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050IGA NephropathyDrug: Fostamatinib Disodium tablet 100 mg;Drug: Fostamatinib Disodium tablet 150 mgRigel PharmaceuticalsNULLWithdrawn18 Years72 YearsBoth0Phase 2NULL
157ChiCTR-IPR-15006760
2015-08-072015-07-16Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical studyEfficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study IgA nephropathyTacrolimus Group :Tacrolimus;Glucocorticoids Group :Glucocorticoids;Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLPending1865BothTacrolimus Group :90;Glucocorticoids Group :90;China
158EUCTR2014-001365-26-IT
(EUCTR)
05/06/201523/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
159EUCTR2014-001365-26-ES
(EUCTR)
27/05/201527/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
160EUCTR2014-001365-26-SE
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2/3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
161EUCTR2014-001365-26-HU
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Belarus;Portugal;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Georgia;Bulgaria;Germany;Japan;Sweden
162NCT02282930
(ClinicalTrials.gov)
March 201531/10/2014Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of ProgressionAn Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of ProgressionProgressive IgA Nephropathy;ProteinuriaDrug: ACTH (Acthar) GelMayo ClinicMallinckrodtCompleted18 YearsN/AAll20Phase 3United States
163EUCTR2014-003402-33-SE
(EUCTR)
12/02/201529/12/2014An open-label phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with IgA Nephropathy on stable RAAS blockade.An open-label phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with IgA Nephropathy on stable RAAS blockade. IgAN is reported as the most common glomerulonephritis worldwide. It is associated with a wide spectrum of disease severity and rate of progression of renal failure.
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CCX168
Other descriptive name: CCX168
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Sweden
164EUCTR2014-003402-33-BE
(EUCTR)
09/02/201511/12/2014An open-label phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with IgA Nephropathy on stable RAAS blockade.An open-label phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with IgA Nephropathy on stable RAAS blockade. IgAN is reported as the most common glomerulonephritis worldwide. It is associated with a wide spectrum of disease severity and rate of progression of renal failure.
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CCX168
Other descriptive name: CCX168
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Sweden
165EUCTR2014-001365-26-DE
(EUCTR)
02/02/201507/08/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 19.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
166NCT02382523
(ClinicalTrials.gov)
February 20159/1/2015Acthar on Proteinuria in IgA Nephropathy PatientsImpact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range ProteinuriaIgA Nephropathy;ProteinuriaDrug: Acthar 80 unit injectionBaylor College of MedicineNULLWithdrawn18 YearsN/AAll0Phase 4United States
167NCT02351752
(ClinicalTrials.gov)
January 201527/1/2015Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled StudyRenal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal DiseasePrimary IgA NephropathyDrug: Hydroxychloroquine SulfateLLiuNULLCompleted18 Years75 YearsBoth20Phase 4China
168NCT02052219
(ClinicalTrials.gov)
October 201429/1/2014BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
169NCT02112838
(ClinicalTrials.gov)
October 201410/4/2014Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) NephropathyA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA NephropathyIGA NephropathyDrug: Fostamatinib 150 mg;Drug: Fostamatinib 100 mg;Drug: PlaceboRigel PharmaceuticalsNULLCompleted18 Years70 YearsAll76Phase 2United States;Austria;Germany;Hong Kong;Taiwan;United Kingdom;Singapore;Switzerland
170NCT02231125
(ClinicalTrials.gov)
September 201430/8/2014Efficacy and Safety of Abelmoschus Manihot for IgA NephropathyEfficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled TrialIgA NephropathyDrug: Losartan;Drug: Abelmoschus manihotChen XiangmeiJiangsu Suzhong Pharmaceutical Group Co., Ltd.Recruiting18 Years65 YearsBoth1600Phase 4China
171EUCTR2014-000331-16-AT
(EUCTR)
25/08/201422/07/2014N/AA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Fostamatinib 100 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Product Name: Fostamatinib 150 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Rigel Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hong Kong;Taiwan;Singapore;Austria;United Kingdom;Switzerland
172EUCTR2014-001365-26-CZ
(EUCTR)
21/08/201422/05/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of
173EUCTR2014-000331-16-GB
(EUCTR)
28/07/201408/05/2014N/AA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Fostamatinib 100 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Product Name: Fostamatinib 150 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Rigel Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom
174NCT02187900
(ClinicalTrials.gov)
June 201422/6/2014Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. fIgA NephropathyDrug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH);Drug: Mycophenolate mofetil (MMF)Second Xiangya Hospital of Central South UniversityNULLRecruiting16 Years65 YearsBoth300Phase 3China
175NCT02160132
(ClinicalTrials.gov)
June 20143/6/2014A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.Glomerulonephritis, IGA;Peripapillary Crescent;Necrosis;Steroid NephropathyDrug: Methylprednisolone(intravenously in the 1st-2nd-3rd month );Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month)Sun Yat-sen UniversityNULLRecruiting14 Years65 YearsBoth180Phase 2China
176NCT01854814
(ClinicalTrials.gov)
July 20139/5/2013The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy PatientsThe Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label StudyIgA NephropathyDrug: Mycophenolate mofetil;Drug: LosartanFan Fan HouNULLRecruiting16 Years70 YearsAll232N/AChina
177NCT02062684
(ClinicalTrials.gov)
June 201312/2/2014BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous AdministrationA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted18 Years65 YearsAll57Phase 2/Phase 3Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain
178EUCTR2012-001923-11-ES
(EUCTR)
09/01/201329/11/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 14.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
179ChiCTR-TRC-13003038
2013-01-012013-01-11Mizoribine for the Treatment of Pediatric IgA NephropathyMizoribine for the Treatment of Pediatric IgA Nephropathy with Moderate Proteinuria--An open, prospective, random, multicenter study IgA nephropathyMZR:mizoribine tablet 4 mg/kg a day (not more than 150 mg/d), qd, po + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po;CVT:Lotensin, 0.2 mg/kg a day (not more than 10 mg/d), qd, po + + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po;Peking University First HospitalNULLCompleted618BothMZR:60;CVT:60;China
180NCT01781312
(ClinicalTrials.gov)
January 201316/1/2013Probiotics in IgA NephropathyProof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN PatientsIgA NephropathyDietary Supplement: ProTectis;Dietary Supplement: GastrusUppsala University HospitalUniversity Hospital, Linkoeping;Karolinska InstitutetNot yet recruiting18 YearsN/ABoth20N/ASweden
181EUCTR2012-001923-11-NL
(EUCTR)
18/12/201219/10/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 16.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
182EUCTR2012-001923-11-DE
(EUCTR)
10/12/201222/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
183NCT01758120
(ClinicalTrials.gov)
December 201212/12/2012Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyA Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyIgA NephropathyDrug: prednisone plus cyclophosphamide;Drug: Prednisone aloneGuangdong General HospitalNULLActive, not recruiting18 Years70 YearsAll135Phase 4China
184NCT01738035
(ClinicalTrials.gov)
December 201225/7/2012The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal DiseaseA Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal DiseasePrimary IgA NephropathyDrug: NEFECON;Other: PlaceboPharmalink ABNULLCompleted18 YearsN/ABoth150Phase 2Belgium;Czech Republic;Denmark;Finland;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
185EUCTR2012-001923-11-SE
(EUCTR)
21/11/201203/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
186EUCTR2012-001923-11-BE
(EUCTR)
19/11/201222/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
187EUCTR2012-001923-11-GB
(EUCTR)
06/11/201228/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
188EUCTR2012-001923-11-DK
(EUCTR)
05/11/201214/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
189EUCTR2012-001923-11-CZ
(EUCTR)
24/10/201216/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
190EUCTR2012-001923-11-FI
(EUCTR)
17/10/201215/08/2012A study to assess if two different doses of Nefecon (budesonide) compared to placebo are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
191EUCTR2012-001923-11-IT
(EUCTR)
27/09/201224/09/2012A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial Primary IgA nephropathy at risk of developing end stage renal disease
MedDRA version: 15.0;Level: LLT;Classification code 10037034;Term: Proteinuria present;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: A07EA06
INN or Proposed INN: BUDESONIDE
CROWN OYNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
192ChiCTR-TRC-12002228
2012-06-152012-02-03The Clinical Study on the Dispelling Wind-dampness of IgA NephropathyThe Clinical Study on the Dispelling Wind-dampness of the chronic nephropathy: The Clinical Study on the Dispelling Wind-dampness of IgA Nephropathy(Multi-center, double-blind, randomized, controlled clinical trial program) IgA NephropathyTreatment group:IgA nephropathy side (granules)+TWP tablet;Control group:Chinese medicine simulation granules + The Tripterygium simulation piece;Hangzhou Hospital of Traditional Chinese MedicineNULLCompleted1665BothTreatment group:114;Control group:114;China
193NCT01560052
(ClinicalTrials.gov)
May 5, 201215/3/2012Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose StudyIgA GlomerulonephritisDrug: methylprednisolone;Drug: PlaceboThe George InstitutePeking University First HospitalCompleted18 YearsN/AAll503N/AAustralia;Canada;China;Hong Kong;India;Malaysia
194NCT02526966
(ClinicalTrials.gov)
March 201217/8/2015Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA NephropathyMulticenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA NephropathyIgA NephropathyBiological: blood sampleCentre Hospitalier Universitaire de Saint EtienneNULLCompleted18 YearsN/AAll68N/AFrance
195NCT02571842
(ClinicalTrials.gov)
January 20126/10/2015Rituximab in Recurrent IgA NephropathyA Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation PathologyRecurrent IgA NephropathyDrug: Intravenous Rituximab;Drug: ACEI/ARB and corticosteroidsChulalongkorn UniversityNULLRecruiting18 Years70 YearsBoth30Phase 4Thailand
196NCT01237028
(ClinicalTrials.gov)
March 20118/11/2010Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System BlockersAdditive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System BlockersIgA NephropathyDrug: CalcitriolYonsei UniversityNULLCompleted20 Years70 YearsBoth168N/AKorea, Republic of
197NCT01451710
(ClinicalTrials.gov)
March 20117/10/2011The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA NephropathyThe Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA NephropathyIgA NephropathyDrug: Prednisone or PrednisoloneNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth30N/AChina
198NCT02523768
(ClinicalTrials.gov)
January 8, 20114/8/2015Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive TreatmentPrevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive TreatmentGlomerulonephritis;IgANDrug: ATG-F;Drug: SimulectCentre Hospitalier Universitaire de Saint EtienneNULLTerminated18 Years75 YearsAll117Phase 4France
199ChiCTR-OPN-16010028
2011-01-012016-11-23Effects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuriaEffects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuria IgA nephropathyPrednisone (PRE) group:1mg/kg prednisone once daily;conventional-dose TW (CTW) group:60 mg TW daily;double-dose TW (DTW) group:?????120mg;Yancheng Third People's HospitalNULLCompleted2154BothPrednisone (PRE) group:10;conventional-dose TW (CTW) group:10;double-dose TW (DTW) group:10;NULL
200ChiCTR-ONC-10001124
2011-01-012010-12-04The effect and safety of mizoribine for IgA Nephropathy in childrenThe effect and safety of mizoribine for IgA Nephropathy in children IgA nephropathy1:mizoribine 3~5mg/kg.d;Nanjing general hospital of Nanjing military commandNULLCompleted516Both1:30;China
201NCT01224028
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsDouble-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA NephropathyIgA NephropathyDrug: Tacrolimus;Drug: PlaceboAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years70 YearsBoth40Phase 2Korea, Republic of
202NCT01269021
(ClinicalTrials.gov)
November 201010/12/2010An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.IgA Nephropathy (IgAN)Drug: mycophenolate mofetil plus lower dose of Prednisone;Drug: Prednisone in full doseZhi-Hong Liu, M.D.NULLCompleted18 Years60 YearsBoth176N/AChina
203NCT01203007
(ClinicalTrials.gov)
September 201015/9/2010Diet Intervention in Food Sensitive Patients With IgA NephropathyA Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA NephropathyIGA NephropathyDietary Supplement: Tailored diet;Dietary Supplement: Low antigen content dietUppsala University HospitalUniversity Hospital, Linkoeping;Haukeland University Hospital;Smerud Medical Research International ASNot yet recruiting18 YearsN/ABoth40N/ANorway;Sweden
204NCT01103778
(ClinicalTrials.gov)
July 201013/4/2010Pilot Study of Velcade® in IgA NephropathyVelcade Therapy for Severe IgA NephropathyChronic Kidney Disease;IgA NephropathyDrug: Bortezomib (Velcade®)The Rogosin InstituteWeill Medical College of Cornell UniversityCompleted18 YearsN/AAll11Phase 4United States
205NCT01184599
(ClinicalTrials.gov)
June 201016/8/2010A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA NephropathyGlomerulonephritis, IGA;HypertensionDrug: aliskirenKagawa UniversityNULLRecruiting16 Years75 YearsBoth30Phase 4Japan
206EUCTR2009-016003-26-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
207ChiCTR-TRC-10000776
2010-02-272010-02-10A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathyA Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy lgA nephropathy;ICD:N03.81:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide;Chinese General Hospital of PLANULLCompleted1855Both1:100;2:100;3:100;4:100;China
208ChiCTR-TRC-13003702
2010-01-012013-10-12Study of Standardized Treatment of Integrative Medicine With the Severe IgA NephropathyStudy of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropathy IgA NephropathyExperimental Group:Chinese Herb Prescription Granule, 6g, Bid, po. 48 weeks;Placebo Comparator:Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48 weeks plus prednisone, 0.5mg-1mg/kg/d, po. 48 weeks;Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese MedicineNULLCompleted1860BothExperimental Group:100;Placebo Comparator:10;China
209ChiCTR-TRC-10000824
2010-01-012010-04-06the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patientsMulticenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients IgA Nephropathythe control group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; placebos 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension(target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;the treatment group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; Fufang Shenyan Tablets 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension (target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;The First Affiliated Hospital of Xi'an Jiaotong University Medical CollegeNULLCompleted1865Boththe control group:60;the treatment group:60;China
210NCT01879514
(ClinicalTrials.gov)
January 201025/3/2013Study of Standardized Treatment of Integrative Medicine With the Severe IgA NephropathStudy of Standardized Treatment of Integrative Medicine With the Severe IgA NephropathIgA NephropathyDrug: Chinese Herb Prescription Granule plus prednisone;Drug: PlaceboShanghai University of Traditional Chinese MedicineShanghai Sixth People's Hospital;RenJi HospitalRecruiting18 Years60 YearsBoth200N/AChina
211JPRN-UMIN000002887
2009/12/0114/12/2009A multicenter study to examine renal protection by a combination of an HMG-CoA reductase inhibitor and losartan in patients with dyslipidemia associated with IgA nephropathy IgA nephropathystatin and losartan group:
simvastatin 5mg and Losartan 50mg/day more than 3 months
statin group:
simvastatin 5mg/day more than 3 months
Fukuoka University Faculty of MedicineNULLRecruiting20years-oldNot applicableMale and Female80Not selectedJapan
212NCT01129557
(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
213NCT00922311
(ClinicalTrials.gov)
July 200914/6/2009Aliskiren for Proteinuric IgAN Despite Angiotensin BlockadeAliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot StudyIgA NephropathyDrug: AliskirenThe University of Hong KongQueen Mary Hospital, Hong Kong;United Christian HospitalCompleted18 Years70 YearsBoth25Phase 4China
214ChiCTR-TRC-09000338
2009-04-012009-02-23Full dose of RASS blockade versus steroids therapy in patients with IgA nephropathyFull dose of RASS blockade versus steroids therapy in patients with IgA nephropathy IgA nephropathyGroup A:Full dose of RASS blockade (ACEI and ARB blocker);Group B:prednisone ;The First Affiliated Hospital of Zhejiang UniversityNULLCompleted1870MaleGroup A:60;Group B:60;China
215NCT00870493
(ClinicalTrials.gov)
April 200926/3/2009Aliskiren for Immunoglobulin A (IgA) NephropathyThe Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over StudyIgA NephropathyDrug: Aliskiren;Drug: PlaceboChinese University of Hong KongNULLCompleted18 Years65 YearsBoth22Phase 3Hong Kong
216NCT00885547
(ClinicalTrials.gov)
March 200920/4/2009Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal UrinalysisProspective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.IgA NephropathyDrug: tripterygium wilfordii (TW)Nanjing University School of MedicineNULLTerminated18 Years60 YearsBoth90N/AChina
217NCT00856674
(ClinicalTrials.gov)
March 20094/3/2009Safety Study of of Intravenous CCL2-LPM in Patients With IgA NephropathyA Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA NephropathyIGA Nephropathy;ProteinuriaBiological: OPL-CCL2-LPMOsprey Pharmaceuticals USA, Inc.NULLTerminated18 YearsN/ABoth30Phase 1Canada
218NCT00498368
(ClinicalTrials.gov)
February 20099/7/2007Rituximab in Progressive Immunoglobulin A (IgA) NephropathyA Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA NephropathyIgA NephropathyDrug: Intravenous Rituximab;Drug: ACE/ARB;Dietary Supplement: Omega-3 Fatty Acid Fish Oil SupplementMayo ClinicOhio State University;Stanford University;University of North Carolina, Chapel Hill;Columbia University;Genentech, Inc.;BiogenCompleted18 Years70 YearsAll34Phase 4United States
219ChiCTR-TRC-09000607
2008-12-012009-11-28Observation for Efficacy of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathyEfficacy Observation of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathy IgA nephropathyA:Methylprednisolone 0.4mg/kg * 8 weeks, reduction to 5mg / d to maintain, MMF 0.75 bid * 6 months after the reduction (weight <50kg, MMF0.5 bid);B:ethylprednisolone 0.4mg/kg*8 weeks, reduction to 5mg / d to maintain;Zhongshan Hospital of Fudan UniversityNULLCompleted1870BothA:40;B:40;China
220EUCTR2007-000443-99-DE
(EUCTR)
09/04/200813/11/2008Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis progressive IgA-Nephritis
MedDRA version: 9.1;Level: LLT;Classification code 10029143;Term: Nephritis-glomerular
Trade Name: Myfortic
INN or Proposed INN: Mycophenolat-Natrium
Trade Name: Decortin H
INN or Proposed INN: Prednisolon
Universitätsklinikum UlmNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
221NCT00554502
(ClinicalTrials.gov)
February 200829/10/2007Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA NephropathySupportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA NephropathyIgA NephropathyDrug: supportive therapy with: ACE-inhibitor / ARB / Statin;Drug: supportive and immunosuppressive therapyRWTH Aachen UniversityNULLCompleted18 Years70 YearsBoth148Phase 3Germany
222EUCTR2007-000871-41-DE
(EUCTR)
24/01/200827/11/2007Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgANSupportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN IgA nephropathy (IgAN) as the most common type of glomerulonephritis.
MedDRA version: 16.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Product Name: Azathioprine
INN or Proposed INN: AZATHIOPRINE
Product Name: Cyclophosphamid
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Prednisolon
INN or Proposed INN: PREDNISOLONE
Product Name: Methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE
Product Name: supportive therapy
RWTH AachenNULLNot RecruitingFemale: yes
Male: yes
148Germany
223NCT00599963
(ClinicalTrials.gov)
January 20082/1/2008Paricalcitol for the Treatment of Immunoglobulin A NephropathyParicalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over StudyIgA NephropathyDrug: paricalcitolChinese University of Hong KongNULLWithdrawn18 Years65 YearsBoth0Phase 3Hong Kong;China
224NCT00549692
(ClinicalTrials.gov)
November 200725/10/2007Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A NephropathyMinimization, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA NephropathyIgA NephropathyDrug: Omega-3 fatty acid ethylester90Kuhnil Pharmaceutical Co., Ltd.Pronova BioPharma ASACompleted18 YearsN/ABoth152Phase 3Korea, Republic of
225NCT00657059
(ClinicalTrials.gov)
September 20078/4/2008Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)IgA NephropathyDrug: irbesartan;Drug: methylprednisolone (MP) or prednisone (pred);Drug: mycophenolate mofetil (MMF)Sun Yat-sen UniversityNULLCompleted14 Years60 YearsAll151Phase 3China
226NCT00793585
(ClinicalTrials.gov)
July 200717/11/2008A Controlled Study of Uric Acid on the Progression of IgA NephropathyA Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA NephropathyIgA NephropathyDrug: allopurinol;Other: continue their usual therapySun Yat-sen UniversityNULLCompleted18 Years70 YearsAll40N/AChina
227NCT00426348
(ClinicalTrials.gov)
May 200723/1/2007A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA NephropathyA Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA NephropathyGlomerulonephritis;IGA NephropathyDrug: Valsartan;Drug: Probucol;Drug: PlaceboGuangdong General HospitalNULLCompleted18 Years60 YearsBoth75Phase 4China
228JPRN-UMIN000002474
2007/01/0101/10/2009Preventive effect of vit K, vit D and, risedronate on 3-dimensional trabecular microstructure in patients with IgA nephropathy on glucocorticoid treatment Glucocorticoid induced osteoporosis in patients with IgA nephropathyMenatetrenone 45mg/day for 6 months
Calcitriol 0.5 microgram/day for 6 months
Risedronate 17.5mg/week for 6 months
Osaka University HospitalDepartment of nephrologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female30Not applicableJapan
229JPRN-UMIN000000593
2006/11/0105/02/2007Randomized controlled trial of mizoribine for progressive IgA nephropathy IgA nephropathy with moderate to severe histological alterationsMethylprednisolone pulse therapy followed by oral prednisolone administration
Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration
West Japan Study Group for Therapy of IgA NephropathyNULLComplete: follow-up complete15years-old60years-oldMale and Female120Not selectedJapan
230NCT00319761
(ClinicalTrials.gov)
May 200627/4/2006Calcitriol in the Treatment of Immunoglobulin A (IgA) NephropathyThe Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A NephropathyIGA NephropathyDrug: CalcitriolChinese University of Hong KongNULLCompleted18 Years65 YearsBoth10Phase 4Hong Kong
231ChiCTR-TRC-06000004
2006-01-012006-09-14ACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trialACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trial primary IgA nephropathygroup 1:treated with ACEI/ARB( ARB therapy is subjected to patients with cough after use of ACEI) Inhibace (cilazapril): start at 1.25mg/day, increase the dose by 1.25mg/day/week to 2.5-5mg/day Cozaar (losartan): 25~50mg/day, increased to 50~100mg/day Last for one year;group 2:Oral prednisone for 6 mos 0.8mg/kg/day x 8 wks Tapered 0.2mg/kg/day/mo in combination with ACEI/ARB;The First Hospital, Peking UniversityNULLCompleted1665Bothgroup 1:78;group 2:78;China
232NCT00396721
(ClinicalTrials.gov)
January 20063/11/2006Sirolimus Therapy for Poor Prognosis Immunoglobulin A NephropathyPilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.Glomerulonephritis, IGA;Nephropathy, IGA;IGA NephropathyDrug: ACE inhibitor + statin;Drug: Sirolimus (study drug)+ACE inhibitor + statinJosep m CruzadoWyeth is now a wholly owned subsidiary of PfizerCompleted18 Years70 YearsBoth23Phase 2Spain
233NCT00378443
(ClinicalTrials.gov)
January 200619/9/2006ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCTGlomerulonephritis, IGADrug: prednisone + Inhibace/Cozaar;Drug: Inhibace/CozaarPeking UniversityNULLActive, not recruiting16 Years65 YearsBothN/ANULL
234EUCTR2005-002610-37-ES
(EUCTR)
05/12/200530/09/2005PILOT TRIAL OF TREATMENT OF POOR-PROGNOSIS IgA NEPHROPATHY WITH LOW EXPOSURE TO SIROLIMUS.Ensayo clínico piloto de tratamiento de la nefropatía IgA con factores de mal pronóstico con dosis bajas de sirolimusPILOT TRIAL OF TREATMENT OF POOR-PROGNOSIS IgA NEPHROPATHY WITH LOW EXPOSURE TO SIROLIMUS.Ensayo clínico piloto de tratamiento de la nefropatía IgA con factores de mal pronóstico con dosis bajas de sirolimus To test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
Trade Name: RAPAMUNE
Product Name: SIROLIMUS
INN or Proposed INN: Sirolimus
NEPHROLOGY DEPARTMENT (HOSPITAL UNIVERSITARY OF BELLVITGE)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Spain
235EUCTR2005-003885-40-IT
(EUCTR)
18/10/200515/01/2007ACE-inhibitors and Angiotensin two receptor antagonists in IgA nephropathy with mild proteinuria - The primary aim of the study consists in testing the hypothesis that blockade of the RAS may decrease the risk of developing adverse effects in patients with benign IgAN.Such blockade would first achieved with unique pharmacological class then shifting to the association of the two classes as soon as ineffective blockade is documented
MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders
Product Name: Ramipril
INN or Proposed INN: Ramipril
Product Name: Irbesartan
INN or Proposed INN: Irbesartan
AZIENDA OSPEDALIERA PROVINCIALE DI LECCONULLNot RecruitingFemale: yes
Male: yes
Italy
236NCT00767221
(ClinicalTrials.gov)
October 20055/10/2008Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyOral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyIGA NephropathyDrug: BudesonidePharmalink ABArchimedes Development LtdCompleted18 YearsN/ABoth20Phase 2Sweden
237JPRN-C000000006
2005/01/0101/08/2005Lisinopril only and a combination of lisinopril and losartan for IgA nephropathy with focal mesangial proliferation in children: A randomized controlled trial of efficacy and safety IgA nephropathy in childrenLisinopril for 2 years
Lisinopril+losartan for 2 years
Japanese Study group of Kidney Disease in ChildrenNULLComplete: follow-up complete2years-old18years-oldMale and Female110Not selectedJapan
238JPRN-C000000341
2004/04/0131/03/2006Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy Refractory IgA nephropathyPrednisolone and anti-thrombocyte and angiotensin II receptor blocker or angiotensin converting enzyme inhibitor
inhibitor
mizoribine and Prednisolone and anti thrombocyte and angiotensin II receptor blocker or angiotensin-converting enzyme
Japanese Study Group of Multiple drug therapy for IgANNULLComplete: follow-up complete16years-old75years-oldMale and Female60Not selectedJapan
239ChiCTR-TRC-09000630
2004-01-012005-09-06Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled TrialTreatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial IgA nephropathyTwo groups:ramipril 5 years versus no treatment;The Chinese University of Hong KongNULLRecruiting00MaleTwo groups:60;China
240JPRN-C000000380
2003/04/0131/03/2006The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial IgA nephropathyARB valsartan

ACE-I enalapril
ARB therapeutic society of IgA nephropathyNULLComplete: follow-up complete16years-old75years-oldMale and Female400Phase 4Japan
241NCT00301600
(ClinicalTrials.gov)
January 200310/3/2006Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA NephropathyMycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA NephropathyIGA NephropathyDrug: Mycophenolate mofetilNanjing University School of MedicineNULLCompleted12 Years65 YearsBoth40N/AChina
242NCT01225445
(ClinicalTrials.gov)
April 200220/10/2010Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled TrialTreatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled TrialBiopsy-confirmed IgA Nephropathy;Proteinuria Less Than 0.5 g Per Day;Normal Blood Pressure;Serum Creatinine Below 120 Umol/lDrug: RamiprilChinese University of Hong KongNULLCompleted18 Years25 YearsBoth60Phase 3Hong Kong
243NCT00863252
(ClinicalTrials.gov)
March 200215/3/2009Mycophenolate Mofetil for IgA NephropathyA Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin BlockadeIGA NephropathyDrug: mycophenolate mofetil;Drug: angiotensin blockadeThe University of Hong KongUnited Christian Hospital;Queen Mary Hospital, Hong KongCompleted18 Years70 YearsBoth40Phase 4China
244NCT00318474
(ClinicalTrials.gov)
January 200224/4/2006Mycophenolate Mofetil (MMF) in Patients With IgA NephropathyA Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA NephropathyIgA NephropathyDrug: Mycophenolate Mofetil (MMF);Drug: MMF Placebo;Drug: ACEi;Drug: FOSSt. Joseph's Hospital and Medical Center, PhoenixNULLTerminated7 Years70 YearsAll184Phase 3United States
245JPRN-C000000363
2001/08/0114/05/2007A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety IgA nephropathy in childrenprednisolone+mizoribine for 2 years
prednisolone+mizoribine+warfarin+dipyridamole for 2 years
The Japanese Pediatric IgA Nephropathy ofTreatment Study GroupNULLComplete: follow-up complete2years-old18years-oldMale and Female80Not selectedJapan
246NCT00006137
(ClinicalTrials.gov)
May 20003/8/2000Pilot Study of Enalapril and Renal Function in Patients With IgA NephropathyIGA GlomerulonephritisDrug: enalaprilNational Center for Research Resources (NCRR)Stanford UniversityCompleted13 Years60 YearsBoth43N/ANULL
247NCT01392833
(ClinicalTrials.gov)
December 19995/7/2011Steroids and Azathioprine in Advanced IgANSteroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter TrialIgA Nephropathy;Chronic Kidney DiseaseDrug: methylprednisolone;Drug: azathioprine;Drug: prednisoneA. Manzoni HospitalNULLCompleted16 Years70 YearsBoth46Phase 3NULL
248JPRN-C000000375
1998/08/0101/04/2006A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children. IgA nephropathy in childrenprednisolone+mizoribine+warfarin+dipyridamole for 2 yearsThe Japanese Pediatric IgA Nephropathy of Treatment Study GroupNULLComplete: follow-up complete2years-old18years-oldMale and Female20Not selectedJapan
249JPRN-C000000373
1998/08/0101/04/2006Lisinopril for IgA nephropathy with focal mesangial proliferation in children IgA nephropathy in childrenLisinopril for 2 yearsThe Japanese Pediatric IgA Nephropathy of Treatment Study GroupNULLComplete: follow-up complete2years-old18years-oldMale and Female50Not selectedJapan
250JPRN-C000000374
1998/08/0101/04/2006A combination of prednisolone, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial proliferation in children. IgA nephropathy in childrenprednisolone+warfarin+dipyridamole for 2 yearsThe Japanese Pediatric IgA Nephropathy ofTreatment Study GroupNULLComplete: follow-up complete2years-old18years-oldMale and Female20Not selectedJapan
251NCT00755859
(ClinicalTrials.gov)
May 199818/9/2008Steroids and Azathioprine Versus Steroids Alone in IgANCorticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.IGA NephropathyDrug: steroids plus azathioprine;Drug: steroidsA. Manzoni HospitalNULLCompleted16 Years70 YearsBoth206Phase 4Italy;Switzerland
252NCT00367562
(ClinicalTrials.gov)
January 199622/8/2006Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA NephropathyPhase IV Open Label Uncontrolled Trial of the Dual Blockade of the Renin Angiotensin System With Enalapril Plus Valsartan Combined With Oral Methylprednisolone for the Treatment of Proteinuria in IGA NephropathyIGA NephropathyDrug: ENALAPRIL VALSARTAN METHYLPREDNISONEHospital BritanicoNULLCompleted21 Years70 YearsBoth20Phase 4Argentina
253EUCTR2021-000621-27-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
254EUCTR2021-000621-27-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
255EUCTR2021-000621-27-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