66. IgA腎症
[臨床試験数:199,薬物数:214(DrugBank:57),標的遺伝子数:32,標的パスウェイ数:128

Searched query = "IgA nephropathy", "IgA nephritis", "Berger disease", "IgA-IgG nephropathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04557462
(ClinicalTrials.gov)
February 17, 202115/9/2020A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label LNP023 in Patients With Primary IgA NephropathyA Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label LNP023 in Patients With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301IgA NephropathyDrug: LNP023Novartis PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll410Phase 3NULL
2NCT04573920
(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.NULLNot yet recruiting18 YearsN/AAll80Phase 2NULL
3NCT04578834
(ClinicalTrials.gov)
January 27, 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 PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll450Phase 3NULL
4EUCTR2020-001049-38-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
5EUCTR2020-003308-14-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 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04573478
(ClinicalTrials.gov)
December 1, 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.NULLNot yet recruiting18 YearsN/AAll320Phase 3NULL
7EUCTR2020-003308-14-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
8NCT04541043
(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 ABNULLNot yet recruiting18 YearsN/AAll250Phase 3NULL
9EUCTR2020-003308-14-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
10EUCTR2020-003308-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2020-003308-14-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
12EUCTR2020-003308-14-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 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
13NCT04438603
(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
14ChiCTR2000038104
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
15ChiCTR2000036468
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04287985
(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;Japan;Korea, Republic of;Spain
17NCT04525729
(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 2410CHENNANNULLRecruiting18 Years75 YearsAll116Phase 4China
18NCT04342325
(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.Recruiting20 YearsN/AAll12Phase 1Japan
19EUCTR2019-002531-29-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
20NCT04291781
(ClinicalTrials.gov)
March 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: placeboRemeGenNULLRecruiting18 Years70 YearsAll30Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-000075-33-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 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;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
22EUCTR2017-000891-27-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
23EUCTR2018-002012-27-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
24NCT04014335
(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
25ChiCTR1900026883
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04042623
(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
27EUCTR2018-000075-33-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
28EUCTR2017-000891-27-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 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
29EUCTR2017-000891-27-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 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
30EUCTR2017-000891-27-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 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04020328
(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
32EUCTR2017-004605-41-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 (NDC# 43547-375-50 approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC
Product Name: over-encapsulated Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: over-encapsulated Irbesartan Tablets
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan approved in the Netherlands
Product Name: over-encapsulated Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets (NDC# 0955-1041-90 approved in the USA)
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
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Czechia;Estonia;Taiwan;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
33NCT03418779
(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
34EUCTR2018-002716-27-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
35EUCTR2018-002716-27-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 2United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-004366-10-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]
University of LeicesterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
21Phase 2United Kingdom
37NCT03841448
(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 PharmaceuticalsNULLRecruiting18 Years65 YearsAll30Phase 2United States;Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom
38EUCTR2018-002716-27-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]Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30Phase 2United States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of
39NCT03945318
(ClinicalTrials.gov)
April 8, 201921/4/2019Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)A Phase 1, 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 DosesAduro Biotech, Inc.NULLRecruiting18 YearsN/AAll92Phase 1United States;United Kingdom
40ChiCTR1900022100
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03468972
(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
42EUCTR2017-004605-41-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
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;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
43EUCTR2017-004605-41-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
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;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
44NCT03762850
(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.NULLRecruiting18 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
45ChiCTR1800019606
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-004605-41-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
47EUCTR2018-000075-33-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]
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of
48NCT03719443
(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
49EUCTR2017-004605-41-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
50EUCTR2017-004605-41-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
Retrophin, 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2018-000075-33-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);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of
52EUCTR2017-004605-41-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
Retrophin, 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
53EUCTR2017-004605-41-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
54EUCTR2018-000075-33-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
55EUCTR2018-000075-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-000075-33-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 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;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
57NCT03643965
(ClinicalTrials.gov)
September 5, 20188/8/2018Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) NephropathyA 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 ABNULLRecruiting18 YearsN/AAll360Phase 3United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom
58EUCTR2017-004605-41-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
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 3Portugal;United States;Estonia;Taiwan;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
59EUCTR2018-000075-33-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 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;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
60EUCTR2017-004902-16-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]
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-004605-41-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
Retrophin, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 3United States;Portugal;Czechia;Estonia;Taiwan;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of
62EUCTR2018-000075-33-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
63EUCTR2017-004902-16-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 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
64EUCTR2018-000075-33-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 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
65EUCTR2017-004902-16-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]
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-000075-33-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 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;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
67EUCTR2018-000075-33-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
68EUCTR2017-004902-16-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 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
69EUCTR2017-004902-16-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
70EUCTR2017-000891-27-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 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2017-000891-27-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 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 AGNovartis Pharma AGNot RecruitingFemale: yes
Male: yes
218Phase 2United States;Taiwan;Finland;Thailand;Italy;United Kingdom;France;Hungary;Czech Republic;Argentina;Belgium;Singapore;Australia;Denmark;Netherlands;Germany;Norway;China;Korea, Republic of;Sweden
72EUCTR2017-000891-27-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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
73EUCTR2017-004902-16-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
74EUCTR2017-000891-27-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 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
75JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2017-004902-16-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 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
77NCT03188887
(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
78EUCTR2017-000891-27-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 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
79NCT03608033
(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
80NCT03373461
(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 PharmaceuticalsNULLRecruiting18 YearsN/AAll146Phase 2United States;Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03453619
(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
82EUCTR2017-000891-27-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;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
83ChiCTR-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
84NCT03366337
(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
85NCT03633864
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2017-000891-27-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
87EUCTR2016-002262-31-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
88JPRN-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
89NCT02808429
(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
90EUCTR2016-004507-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91ChiCTR-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
92NCT03218852
(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
93NCT02942381
(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
94NCT02981212
(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
95NCT02765594
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02712697
(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
97NCT02662283
(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
98NCT02647255
(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 HospitalNULLEnrolling by invitation14 Years65 YearsAll150Phase 2;Phase 3China
99NCT02682407
(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
100NCT03015974
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02605525
(ClinicalTrials.gov)
December 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
102EUCTR2015-002345-64-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
103NCT02433236
(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
104ChiCTR-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
105EUCTR2014-001365-26-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;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2014-001365-26-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
107EUCTR2014-001365-26-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;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
108EUCTR2014-001365-26-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;Phase 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
109NCT02282930
(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
110EUCTR2014-003402-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2014-003402-33-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
112EUCTR2014-001365-26-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
113NCT02382523
(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
114NCT02351752
(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
115NCT02052219
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT02112838
(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
117NCT02231125
(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
118EUCTR2014-000331-16-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
119EUCTR2014-001365-26-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
120EUCTR2014-000331-16-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]Rigel Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
92Phase 2United States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02187900
(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
122NCT02160132
(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
123NCT01854814
(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
124NCT02062684
(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
125EUCTR2012-001923-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126ChiCTR-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
127NCT01781312
(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
128EUCTR2012-001923-11-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
129EUCTR2012-001923-11-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]
Pharmalink ABNULLNot Recruiting Female: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
130NCT01758120
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT01738035
(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
132EUCTR2012-001923-11-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
133EUCTR2012-001923-11-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
134EUCTR2012-001923-11-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
135EUCTR2012-001923-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2012-001923-11-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
137EUCTR2012-001923-11-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
138EUCTR2012-001923-11-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
139ChiCTR-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
140NCT01560052
(ClinicalTrials.gov)
April 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 HospitalActive, not recruiting18 YearsN/AAll503N/AAustralia;Canada;China;Hong Kong;India;Malaysia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02526966
(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
142NCT02571842
(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
143NCT01237028
(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
144NCT01451710
(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
145ChiCTR-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146ChiCTR-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
147NCT02523768
(ClinicalTrials.gov)
January 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 EtienneNULLActive, not recruiting18 Years75 YearsAll115Phase 4France
148NCT01224028
(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
149NCT01269021
(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
150NCT01203007
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01103778
(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
152NCT01184599
(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
153EUCTR2009-016003-26-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
154ChiCTR-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
155ChiCTR-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156ChiCTR-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
157NCT01879514
(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
158JPRN-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
159NCT01129557
(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
160NCT00922311
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161ChiCTR-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
162NCT00870493
(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
163NCT00885547
(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
164NCT00856674
(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
165NCT00498368
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166ChiCTR-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
167EUCTR2007-000443-99-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
168NCT00554502
(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
169EUCTR2007-000871-41-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
170NCT00599963
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT00549692
(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
172NCT00657059
(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
173NCT00793585
(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
174NCT00426348
(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
175JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176JPRN-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
177NCT00319761
(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
178ChiCTR-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
179NCT00396721
(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
180NCT00378443
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2005-002610-37-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
182EUCTR2005-003885-40-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
183NCT00767221
(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
184JPRN-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
185JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186ChiCTR-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
187JPRN-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
188NCT00301600
(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
189NCT01225445
(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
190NCT00863252
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT00318474
(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
192JPRN-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
193NCT00006137
(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
194NCT01392833
(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
195JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196JPRN-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
197JPRN-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
198NCT00755859
(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
199NCT00367562
(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