66. IgA腎症 IgA nephropathy Clinical trials / Disease details
臨床試験数 : 255 / 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05174221 (ClinicalTrials.gov) | May 30, 2022 | 14/12/2021 | A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy | A Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy | Kidney Disease | Drug: Mezagitamab | Takeda | NULL | Not yet recruiting | 18 Years | N/A | All | 16 | Phase 1 | NULL |
| 2 | NCT05125068 (ClinicalTrials.gov) | February 28, 2022 | 8/11/2021 | Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN) | A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy | IgA Nephropathy;IgAN | Drug: AT-1501 | Eledon Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 99 Years | All | 42 | Phase 2 | NULL |
| 3 | NCT05083364 (ClinicalTrials.gov) | February 2, 2022 | 8/10/2021 | Study of ARO-C3 in Adult Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria and Complement-Mediated Renal Disease | A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Adult Patients With Complement-Mediated Renal Disease | Paroxysmal Nocturnal Hemoglobinuria;C3 Glomerulopathy;IgA Nephropathy | Drug: ARO-C3;Drug: Placebo | Arrowhead Pharmaceuticals | NULL | Recruiting | 18 Years | 70 Years | All | 62 | Phase 1 | New Zealand |
| 4 | EUCTR2021-000621-27-IT (EUCTR) | 11/01/2022 | 12/10/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: [RE-021] INN or Proposed INN: Sparsentan | TRAVERE THERAPEUTICS, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2020-002200-40-DK (EUCTR) | 11/01/2022 | 02/07/2021 | A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy | A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 427 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 6 | EUCTR2020-003084-26-CZ (EUCTR) | 24/11/2021 | 13/07/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 7 | EUCTR2020-004892-41-DE (EUCTR) | 16/11/2021 | 09/06/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | Belarus;United States;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Malaysia;Belgium;Poland;Australia;Germany;Korea, Republic of | ||
| 8 | NCT04905212 (ClinicalTrials.gov) | November 4, 2021 | 21/5/2021 | A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy | A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Telitacicept 160mg;Drug: Telitacicept 240mg;Drug: Placebo | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | United States |
| 9 | EUCTR2020-002200-40-NO (EUCTR) | 14/10/2021 | 26/08/2021 | A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy | A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 427 | Phase 3 | Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden;United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France | ||
| 10 | EUCTR2018-000075-33-GR (EUCTR) | 13/10/2021 | 13/07/2021 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Greece;Thailand;Spain;Italy;Australia;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 11 | EUCTR2020-005855-19-ES (EUCTR) | 11/10/2021 | 05/08/2021 | Evaluating oral BCX9930 in renal diseases | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW | complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride | BioCryst Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France;Spain;Germany;United Kingdom;Italy | ||
| 12 | EUCTR2021-000621-27-ES (EUCTR) | 08/10/2021 | 27/07/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States;Poland | ||
| 13 | EUCTR2020-005855-19-IT (EUCTR) | 01/10/2021 | 22/10/2021 | Evaluating oral BCX9930 in renal diseases | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW | complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride | BIOCRYST PHARMACEUTICALS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France;Spain;Germany;United Kingdom;Italy | ||
| 14 | NCT04557462 (ClinicalTrials.gov) | September 20, 2021 | 15/9/2020 | A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy | A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301 | Primary IgA Nephropathy | Drug: LNP023 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 410 | Phase 3 | Belgium;Germany |
| 15 | EUCTR2020-002200-40-NL (EUCTR) | 14/09/2021 | 23/07/2021 | A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy | A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 427 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 16 | NCT05016323 (ClinicalTrials.gov) | September 9, 2021 | 17/8/2021 | A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. | A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. | IgA Nephropathy | Drug: HR19042 Capsules;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 210 | Phase 2 | China |
| 17 | EUCTR2020-004892-41-GR (EUCTR) | 06/09/2021 | 19/07/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | United States;Belarus;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Belgium;Malaysia;Poland;Australia;Germany;Korea, Republic of | ||
| 18 | NCT05065970 (ClinicalTrials.gov) | August 31, 2021 | 14/9/2021 | Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | Immunoglobulin A (IgA) Nephropathy | Drug: Felzartamab;Other: Placebo | MorphoSys AG | NULL | Recruiting | 18 Years | 80 Years | All | 48 | Phase 2 | United States;Australia;Belgium;Bulgaria;Germany;Korea, Republic of;Malaysia;Serbia;Spain;Ukraine;United Kingdom |
| 19 | EUCTR2020-005054-19-DE (EUCTR) | 16/08/2021 | 01/04/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 20 | EUCTR2020-002200-40-DE (EUCTR) | 05/08/2021 | 24/06/2021 | A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy | A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 427 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 21 | EUCTR2020-005054-19-CZ (EUCTR) | 28/07/2021 | 09/03/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 22 | EUCTR2020-003084-26-PL (EUCTR) | 13/07/2021 | 28/01/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 23 | EUCTR2020-005054-19-ES (EUCTR) | 08/07/2021 | 09/07/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 23.1;Level: PT;Classification code 10084204;Term: Sickle cell nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 24 | NCT04887532 (ClinicalTrials.gov) | July 1, 2021 | 13/5/2021 | A Trial of HR19042 Capsule in Healthy Chinese Subjects | Safety and Pharmacokinetics of HR19042 Capsule After Single Administration in Healthy Chinese Subjects | Primary IgA Nephropathy | Drug: HR19042 capsule | Jiangsu HengRui Medicine Co., Ltd. | NULL | Completed | 18 Years | 45 Years | All | 12 | Phase 1 | China |
| 25 | EUCTR2020-005054-19-BG (EUCTR) | 30/06/2021 | 18/03/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Serbia;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 26 | EUCTR2020-005054-19-BE (EUCTR) | 30/06/2021 | 07/05/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Serbia;Philippines;Czechia;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 27 | EUCTR2020-001537-13-DE (EUCTR) | 30/06/2021 | 29/01/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 28 | EUCTR2020-003084-26-IT (EUCTR) | 08/06/2021 | 08/06/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - ALIGN | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atrasentan Product Code: [Atrasentan] INN or Proposed INN: Atrasentan | CHINOOK THERAPEUTICS, U.S., Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 29 | JPRN-jRCT2071210028 | 01/06/2021 | 25/05/2021 | The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function | A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function - The ALIGN Study | IgA Nephropathy at Risk of Progressive Loss of Renal Function | Drug: Atrasentan Film-coated tablet Other Names: CHK-01 Atrasentan Hydrochloride ABT-627 Drug: Placebo Film-coated tablet | Yamada Shuji | NULL | Pending | >= 18age old | Not applicable | Both | 24 | Phase 3 | Argentina;Australia;Brazil;Canada;China;Colombia;Czech Republic;France;Germany;Hong Kong;India;Italy;New Zealand;Poland;South Korea;Spain;Taiwan;United Kingdom;United States;Japan |
| 30 | NCT04833374 (ClinicalTrials.gov) | May 24, 2021 | 4/4/2021 | Steroids Therapy in IgA Nephropathy With Crescents | Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. | IgA Nephropathy | Drug: Methylprednisolone | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 14 Years | 65 Years | All | 200 | Phase 3 | China |
| 31 | EUCTR2020-001537-13-IT (EUCTR) | 19/05/2021 | 08/06/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN) - Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: [ALXN1210] INN or Proposed INN: Ravulizumab | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden | ||
| 32 | NCT04716231 (ClinicalTrials.gov) | May 18, 2021 | 11/1/2021 | Atacicept in Subjects With IgA Nephropathy | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN) | IgA Nephropathy;Berger Disease | Biological: Atacicept;Other: Placebo to match Atacicept | Vera Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States;Australia;Belgium;Czechia;Germany;Greece;India;Korea, Republic of;Malaysia;Turkey;United Kingdom |
| 33 | EUCTR2020-001049-38-CZ (EUCTR) | 13/05/2021 | 02/02/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 34 | EUCTR2020-001049-38-NL (EUCTR) | 04/05/2021 | 17/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 35 | EUCTR2020-001537-13-ES (EUCTR) | 29/04/2021 | 09/02/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 36 | EUCTR2020-001537-13-SE (EUCTR) | 23/04/2021 | 29/01/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 37 | ChiCTR2100045306 | 2021-04-10 | 2021-04-10 | A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy | A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy | IgA nephropathy | Hydroxychloroquine group:Hydroxychloroquine and Kunxian capsule placebo;Kunxian capsule group:Kunxian capsule and Hydroxychloroquine placebo;Placebo group:Kunxian capsule and Hydroxychloroquine placebo; | Peking University First Hospital | NULL | Recruiting | 18 | Both | Hydroxychloroquine group:65;Kunxian capsule group:65;Placebo group:65; | China | ||
| 38 | EUCTR2020-003084-26-DE (EUCTR) | 08/04/2021 | 21/12/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 39 | ChiCTR2100052910 | 2021-04-01 | 2021-11-06 | To investigate the efficacy and safety of hydroxychloroquine in IgA nephropathy based on PPK model | Efficacy and safety evaluation of hydroxychloroquine in the treatment of IgA nephropathy | IgA nephropathy | Experimental group:RAASi + hydroxychloroquine ;Cotrol group :RAASi+placebo ; | Department of Pharmacy, Drum Tower Hospital Affiliated to Nanjing University Medical School | NULL | Recruiting | 18 | 75 | Both | Experimental group:50;Cotrol group :50; | Phase 1 | China |
| 40 | EUCTR2020-001049-38-NO (EUCTR) | 16/03/2021 | 19/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 41 | ChiCTR2100042331 | 2021-03-01 | 2021-01-19 | Effect evaluation and related mechanism research on different stages of IgA nephropathy treated by supplementing Qi, nourishing Yin and removing blood stasis | Effect evaluation and related mechanism research on different stages of IgA nephropathy treated by supplementing Qi, nourishing Yin and removing blood stasis | IgAN | treatment group:Add or subtract Shenqi Dihuang soup;treatment group:Remove blood stasis and remove cloudy drink;matched group:Nil;matched group:Nil; | Zhejiang Provincal Hospital of Traditional Chinese Medicine | NULL | Recruiting | 18 | 75 | Both | treatment group:35;treatment group:60;matched group:35;matched group:60; | China | |
| 42 | EUCTR2020-001049-38-IT (EUCTR) | 24/02/2021 | 20/05/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallelgroup, phase III study to evaluate the efficacy and safety of LNP023 inprimary IgA nephropathy patients - Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ACTHIB - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE+1 SIRINGA PRERIEMPITA SOLVENTE 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO - POLV.E SOLUZ.PER SOLUZ. INIETT.-USO INTRAMUSCOLARE-COMP. CONIUG.LIOFILIZZ.MENA:FLAC.(VETRO) COMP. GONIUG.LIQUI.MENCWY:FLAC.(VETRO)-1 FLAC+1FLAC Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO Trade Name: BEXSERO - SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA PRERIEMPITA (VETRO) - 0.5ML - 1 SIRINGA PRERIEMPITA CON AGO Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 43 | EUCTR2020-001049-38-SE (EUCTR) | 23/02/2021 | 02/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 44 | EUCTR2020-003308-14-FI (EUCTR) | 22/02/2021 | 27/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 45 | EUCTR2020-001049-38-BE (EUCTR) | 17/02/2021 | 17/02/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 46 | NCT04573920 (ClinicalTrials.gov) | February 1, 2021 | 28/9/2020 | Atrasentan in Patients With Proteinuric Glomerular Diseases | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases | IgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A Nephropathy | Drug: Atrasentan | Chinook Therapeutics U.S., Inc. | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom |
| 47 | NCT04578834 (ClinicalTrials.gov) | January 25, 2021 | 9/9/2020 | Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | A 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 | Drug: Placebo;Drug: LNP023 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 450 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Russian Federation;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Vietnam |
| 48 | EUCTR2020-001049-38-FR (EUCTR) | 13/01/2021 | 02/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 49 | EUCTR2020-001049-38-DK (EUCTR) | 07/01/2021 | 11/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 50 | EUCTR2020-001049-38-FI (EUCTR) | 31/12/2020 | 10/12/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden | ||
| 51 | EUCTR2020-001049-38-HU (EUCTR) | 17/12/2020 | 27/10/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United 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 | ||
| 52 | EUCTR2020-001049-38-DE (EUCTR) | 17/12/2020 | 06/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden | ||
| 53 | NCT04573478 (ClinicalTrials.gov) | December 11, 2020 | 12/9/2020 | Atrasentan in Patients With IgA Nephropathy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function | IgA Nephropathy;Immunoglobulin A Nephropathy | Drug: Atrasentan;Drug: Placebo | Chinook Therapeutics U.S., Inc. | NULL | Recruiting | 18 Years | N/A | All | 320 | Phase 3 | United States;Australia;Brazil;Canada;France;Germany;Hong Kong;Italy;Japan;Korea, Republic of;New Zealand;Poland;Spain;Taiwan |
| 54 | EUCTR2020-003308-14-GR (EUCTR) | 03/12/2020 | 26/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 55 | EUCTR2020-003308-14-PL (EUCTR) | 24/11/2020 | 01/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 56 | ChiCTR2000040161 | 2020-11-15 | 2020-11-23 | Study on dose-effect relationship and safety of Modified Huangqi Chifeng Decoction with different doses of Astragalus in the treatment of IgA nephroproteinuria | Study on dose-effect relationship and safety of Modified Huangqi Chifeng Decoction with different doses of Astragalus in the treatment of IgA nephroproteinuria | IgA nephropathy | control group:Placebo + telmisartan tablet;Experimental group 1:Modified Huangqi Chifeng Decoction 1 + telmisartan tablet;Experimental group 2:Modified Huangqi Chifeng Decoction 2 + telmisartan tablet;Experimental group 3:Modified Huangqi Chifeng Decoction 3 + telmisartan tablet; | Xiyuan Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | Both | control group:30;Experimental group 1:30;Experimental group 2:30;Experimental group 3:30; | N/A | China | ||
| 57 | NCT04541043 (ClinicalTrials.gov) | November 14, 2020 | 1/9/2020 | Efficacy 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-301 | Primary IgA Nephropathy | Drug: Nefecon | Calliditas Therapeutics AB | NULL | Recruiting | 18 Years | N/A | All | 250 | Phase 3 | Sweden |
| 58 | EUCTR2020-003308-14-FR (EUCTR) | 13/11/2020 | 13/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of | ||
| 59 | EUCTR2020-003308-14-IT (EUCTR) | 12/11/2020 | 24/05/2021 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 60 | EUCTR2020-003308-14-GB (EUCTR) | 12/11/2020 | 21/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 61 | EUCTR2020-003308-14-SE (EUCTR) | 21/10/2020 | 18/09/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Korea, Republic of;Sweden;Germany;Australia;Belgium;Poland;Argentina;Canada;Czech Republic;France;Italy;United Kingdom;Turkey;Spain;Finland;Greece;Taiwan;Belarus;United States | ||
| 62 | EUCTR2020-003308-14-CZ (EUCTR) | 21/10/2020 | 16/09/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | 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-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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of | ||
| 63 | NCT04438603 (ClinicalTrials.gov) | October 1, 2020 | 17/6/2020 | The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy | The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy | IgA Nephropathy | Drug: Intervention for incipient patients at low risk of disease progression;Drug: Intervention for patients at high risk of disease progression | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | RenJi Hospital;Shanghai Zhongshan Hospital;Longhua Hospital Shanghai University of Traditional Chinese Medicine | Recruiting | 18 Years | 80 Years | All | 180 | China | |
| 64 | ChiCTR2000038104 | 2020-09-01 | 2020-09-10 | Efficacy 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 nephropathy | Group 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 Medicine | NULL | Recruiting | Both | Group 1:40;Group 2:40;The control group:40; | China | |||
| 65 | ChiCTR2000036468 | 2020-08-25 | 2020-08-23 | A Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA Nephropathy | A Multicentre, Randomized, Controlled Trial of Rituximab in Treatment of Primary IgA Nephropathy | IgAN | Rituximab group:Rituximab+RASi;control group:RASi; | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | NULL | Recruiting | 18 | 75 | Both | Rituximab group:58;control group:58; | Phase 4 | China |
| 66 | NCT04287985 (ClinicalTrials.gov) | July 20, 2020 | 10/2/2020 | Safety and Efficacy Study of VIS649 for IgA Nephropathy | A 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 Nephropathy;Glomerular Disease;IgAN | Drug: Dose-Placebo;Drug: Low Dose-VIS649;Drug: Medium Dose-VIS649;Drug: High Dose-VIS649 | Visterra, Inc. | NULL | Recruiting | 18 Years | N/A | All | 144 | Phase 2 | United States;Australia;Canada;Hong Kong;India;Japan;Korea, Republic of;Malaysia;Philippines;Singapore;Spain;Sri Lanka;Taiwan;Thailand;United Kingdom |
| 67 | NCT04525729 (ClinicalTrials.gov) | July 1, 2020 | 17/8/2020 | Rituximab and RASi in Patients With IgAN | A Multicentre, Randomized, Controlled Study of Rituximab in Treatment of Primary IgA Nephropathy | IgA Nephropathy | Drug: Rituximab;Drug: RAS 2410 | CHENNAN | Dongfang Hospital Affiliated to Tongji University;Shanghai Pudong New Area People's Hospital;Ruijin Hospital North Shanghai Jiao Tong University School of Medicine;Ningbo Municipal Yinzhou District No.2 Hospital;Third Affiliated Hospital, Sun Yat-Sen University;Xiamen Hongai Hospital;Sir Run Run Shaw Hospital | Recruiting | 18 Years | 75 Years | All | 116 | Phase 4 | China |
| 68 | NCT04342325 (ClinicalTrials.gov) | June 15, 2020 | 8/4/2020 | The Clinical Trial of ADR-001 for IgA Nephropathy | Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy | Glomerulonephritis , IGA | Biological: infusion of ADR-001 (Mesenchymal stem cell) | Nagoya University | Rohto Pharmaceutical Co., Ltd. | Active, not recruiting | 20 Years | N/A | All | 9 | Phase 1 | Japan |
| 69 | NCT04291781 (ClinicalTrials.gov) | April 13, 2020 | 27/2/2020 | A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) Nephropathy | Phase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of IgA Nephropathy | IgA Nephropathy | Biological: RC18 160mg;Biological: RC18 240mg;Biological: placebo | RemeGen Co., Ltd. | NULL | Completed | 18 Years | 70 Years | All | 44 | Phase 2 | China |
| 70 | EUCTR2019-002531-29-GB (EUCTR) | 24/03/2020 | 17/12/2019 | A study to look at the effect and how safe drug VIS649 is in patients with kidney disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Thailand;Spain;United Kingdom;India;Czech Republic;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of | ||
| 71 | EUCTR2018-000075-33-DE (EUCTR) | 19/12/2019 | 01/07/2019 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 72 | EUCTR2017-000891-27-IT (EUCTR) | 18/12/2019 | 30/09/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 73 | EUCTR2018-002012-27-GB (EUCTR) | 09/12/2019 | 08/10/2019 | Testing the Safety and Activity of Sparsentan in the Treatment of Patients with IgA Nephropathy | A 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 Leicester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | United Kingdom | ||
| 74 | NCT04014335 (ClinicalTrials.gov) | December 4, 2019 | 8/7/2019 | A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy | An 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 Nephropathy | Primary IgA Nephropathy | Drug: IONIS-FB-LRx | Ionis Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 10 | Phase 2 | Australia;Canada;New Zealand |
| 75 | ChiCTR1900026883 | 2019-12-01 | 2019-10-25 | A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy | A prospective randomized controlled trial of a new method for glucocorticoid intervention in progressive IgA nephropathy | IgA nephropathy | 1:0.5mg/kg.d prednisolone induced remission;2:0.8mg/kg.d prednisolone induced remission ; | Nephrology Department, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Province | NULL | Pending | 18 | 72 | Both | 1:71;2:71; | China | |
| 76 | NCT04042623 (ClinicalTrials.gov) | November 27, 2019 | 31/7/2019 | Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy | An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy | IgA Nephropathy | Drug: AVB-S6-500 | Aravive, Inc. | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 77 | EUCTR2018-000075-33-GB (EUCTR) | 06/11/2019 | 27/06/2019 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United 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 | ||
| 78 | EUCTR2017-000891-27-FR (EUCTR) | 29/10/2019 | 12/08/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 79 | EUCTR2017-000891-27-CZ (EUCTR) | 10/10/2019 | 03/07/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 80 | EUCTR2018-000075-33-IT (EUCTR) | 26/09/2019 | 18/06/2021 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: OMS721 Product Code: [OMS721] INN or Proposed INN: OMS721 | OMEROS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden | ||
| 81 | EUCTR2017-000891-27-HU (EUCTR) | 25/09/2019 | 30/07/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore | ||
| 82 | NCT04020328 (ClinicalTrials.gov) | September 12, 2019 | 10/7/2019 | Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency | A Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal Insufficiency | Glomerulonephritis, IGA;Renal Insufficiency, Chronic | Drug: Leflunomide 20 mg+prednisone 0.5mg/kg/d | Shenzhen Second People's Hospital | NULL | Recruiting | 14 Years | 65 Years | All | 70 | Phase 4 | China |
| 83 | EUCTR2017-004605-41-DE (EUCTR) | 20/07/2019 | 25/06/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/Overencapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (ANDA 203071) Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (NDA 020 757) Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 84 | NCT03418779 (ClinicalTrials.gov) | July 4, 2019 | 11/1/2018 | Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD | Treatment 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 ESRD | Drug: The Yi-Qi-Qing-Jie herbal compound;Drug: Immunosuppressants;Other: Optimized Supportive Care;Other: Yi-Qi-Qing-Jie herbal compound placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | China Academy of Chinese Medical Sciences | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2/Phase 3 | China |
| 85 | EUCTR2018-002716-27-GB (EUCTR) | 11/06/2019 | 07/01/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden | ||
| 86 | EUCTR2018-002716-27-SE (EUCTR) | 28/05/2019 | 06/02/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | France;United States;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden | ||
| 87 | EUCTR2017-004366-10-GB (EUCTR) | 24/05/2019 | 04/02/2019 | Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | Immunoglobulin A (IgA) nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® (belimumab) Product Name: BENLYSTA® (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab Other descriptive name: GSK1550188; Benlysta | University of Leicester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 21 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 88 | NCT03841448 (ClinicalTrials.gov) | April 24, 2019 | 13/2/2019 | A 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 Nephropathy | IgA Nephropathy (IgAN);Berger Disease;Glomerulonephritis, IgA | Drug: Placebo;Drug: Cemdisiran | Alnylam Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 65 Years | All | 31 | Phase 2 | Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom;United States |
| 89 | NCT03945318 (ClinicalTrials.gov) | April 8, 2019 | 21/4/2019 | Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) | A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy | IgA Nephropathy | Drug: BION-1301 Single Dose;Drug: Placebo Single Dose;Drug: BION-1301 Multiple Doses;Drug: Placebo Multiple Doses | Chinook Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 112 | Phase 1/Phase 2 | United States;United Kingdom |
| 90 | EUCTR2018-002716-27-ES (EUCTR) | 08/04/2019 | 12/04/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of | ||
| 91 | ChiCTR1900022100 | 2019-04-01 | 2019-03-25 | Evaluation 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 nephropathy | Placebo Group:Placebo+telmisartan;Experimental group:Flavoured huangqi chifeng granules+telmisartan; | Xiyuan Hospital, China Academy of Chinese Medical Sciences | NULL | Recruiting | Both | Placebo Group:40;Experimental group:40; | N/A | China | ||
| 92 | NCT03468972 (ClinicalTrials.gov) | March 2019 | 12/3/2018 | Effect of Immunosuppression in IgA Nephropathy | Effect of Immunosuppression in IgA Nephropathy | Biopsy-proven IgA Nephropathy | Drug: Immunosuppressive treatment;Other: intensive supportive care | Yonsei University | NULL | Not yet recruiting | 19 Years | 75 Years | All | 174 | Phase 4 | Korea, Republic of |
| 93 | EUCTR2017-004605-41-PT (EUCTR) | 04/02/2019 | 24/08/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 94 | EUCTR2017-004605-41-PL (EUCTR) | 17/01/2019 | 05/11/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/over-encapsulated Spasenten tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United 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 | ||
| 95 | NCT03762850 (ClinicalTrials.gov) | December 20, 2018 | 27/11/2018 | A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy | 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 | Drug: sparsentan;Drug: irbesartan | Travere Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 380 | Phase 3 | United States;Australia;Belgium;Croatia;Czechia;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;Lithuania;New Zealand;Poland;Portugal;Spain;Taiwan;United Kingdom |
| 96 | ChiCTR1800019606 | 2018-12-01 | 2018-11-19 | Effect of kunxian capsule and leflunomide on IgA nephropathy | Effect of kunxian capsule and leflunomide on IgA nephropathy | IgA nephropathy | 1:Kun-Xian Capsule;2:Leflunomide; | The First Affiliated Hospital of Chengdu Medical College | NULL | Pending | 15 | 75 | Both | 1:20;2:20; | China | |
| 97 | EUCTR2017-004605-41-HR (EUCTR) | 23/11/2018 | 16/05/2019 | Effectiveness 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 98 | EUCTR2017-004902-16-IT (EUCTR) | 16/11/2018 | 20/01/2021 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primar | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: [Nefecon] INN or Proposed INN: BUDESONIDE | CALLIDITAS THERAPEUTICS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 99 | EUCTR2018-000075-33-AT (EUCTR) | 15/11/2018 | 25/06/2018 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | ||
| 100 | EUCTR2017-004605-41-IT (EUCTR) | 25/10/2018 | 28/01/2021 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan compresse Product Code: [RE-021] Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets Product Code: C09 Trade Name: SMOFKABIVEN - EMULSIONE PER INFUSIONE SENZA ELETTROLITI 1 SACCA BIOFINE MULTICOMPARTIMENTATE DA 493 ML Product Name: over-encapsulated Irbesartan Tablets Product Code: [000000000] INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | RETROPHIN, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 101 | NCT03719443 (ClinicalTrials.gov) | October 9, 2018 | 10/10/2018 | First in Human Study to Assess Safety of VIS649 in Healthy Subjects | A 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 Subjects | Immunoglobulin A Nephropathy;IgAN - IgA Nephropathy;IgA Nephropathy | Biological: VIS649;Biological: Placebo | Visterra, Inc. | NULL | Completed | 18 Years | 55 Years | All | 41 | Phase 1 | United States |
| 102 | EUCTR2017-004605-41-GB (EUCTR) | 04/10/2018 | 04/06/2018 | Effectiveness 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 103 | EUCTR2018-000075-33-BE (EUCTR) | 03/10/2018 | 31/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 104 | EUCTR2017-004605-41-CZ (EUCTR) | 03/10/2018 | 17/07/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 105 | EUCTR2017-004605-41-BE (EUCTR) | 28/09/2018 | 06/07/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/ Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United 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 | ||
| 106 | EUCTR2017-004605-41-ES (EUCTR) | 27/09/2018 | 30/07/2018 | Effectiveness 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Portugal;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 | ||
| 107 | EUCTR2018-000075-33-PL (EUCTR) | 17/09/2018 | 10/07/2018 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 108 | EUCTR2018-000075-33-CZ (EUCTR) | 06/09/2018 | 06/04/2018 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United 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 | ||
| 109 | EUCTR2017-004605-41-EE (EUCTR) | 05/09/2018 | 31/07/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | United 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 | ||
| 110 | EUCTR2018-000075-33-BG (EUCTR) | 05/09/2018 | 19/07/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 111 | NCT03643965 (ClinicalTrials.gov) | September 5, 2018 | 8/8/2018 | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | Primary IgA Nephropathy | Drug: Nefecon;Drug: Placebo oral capsule | Calliditas Therapeutics AB | NULL | Active, not recruiting | 18 Years | N/A | All | 365 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom |
| 112 | EUCTR2018-000075-33-SE (EUCTR) | 03/09/2018 | 03/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;China;Sweden;Korea, Republic of | ||
| 113 | EUCTR2017-004902-16-PL (EUCTR) | 27/08/2018 | 18/07/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada | ||
| 114 | EUCTR2017-004605-41-LT (EUCTR) | 23/08/2018 | 02/07/2018 | Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN) | A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy | Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan tablets/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of | ||
| 115 | EUCTR2018-000075-33-ES (EUCTR) | 01/08/2018 | 21/05/2018 | OMS721 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Slovakia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Sweden | ||
| 116 | EUCTR2017-004902-16-FI (EUCTR) | 18/07/2018 | 02/03/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 117 | EUCTR2018-000075-33-SK (EUCTR) | 21/06/2018 | 20/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United 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 | ||
| 118 | EUCTR2017-004902-16-BE (EUCTR) | 18/06/2018 | 21/02/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 119 | EUCTR2018-000075-33-LT (EUCTR) | 15/06/2018 | 23/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 120 | EUCTR2018-000075-33-HU (EUCTR) | 07/06/2018 | 29/03/2018 | OMS721 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 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Hungary;Canada;Australia | ||
| 121 | EUCTR2017-004902-16-CZ (EUCTR) | 04/06/2018 | 12/02/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 122 | EUCTR2017-004902-16-GB (EUCTR) | 29/05/2018 | 22/06/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 123 | EUCTR2017-000891-27-DK (EUCTR) | 25/05/2018 | 11/04/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 124 | EUCTR2017-000891-27-NL (EUCTR) | 25/05/2018 | 09/04/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 125 | EUCTR2017-000891-27-BE (EUCTR) | 22/05/2018 | 19/03/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 126 | EUCTR2017-004902-16-ES (EUCTR) | 09/04/2018 | 02/03/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden | ||
| 127 | EUCTR2017-000891-27-DE (EUCTR) | 06/04/2018 | 24/11/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Belgium;Singapore;Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil | ||
| 128 | JPRN-UMIN000032031 | 2018/04/01 | 01/04/2018 | The steroid internal use method for patients with IgA nephropathy | The steroid internal use method for patients with IgA nephropathy - The steroid internal use method for patients with IgA nephropathy | IgA nephropathy | Prednisolone 0.5mg/kg/every other day group Prednisolone 0.25mg/kg/everyday group | Juntendo University | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan |
| 129 | EUCTR2017-004902-16-SE (EUCTR) | 28/03/2018 | 13/02/2018 | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 130 | NCT03188887 (ClinicalTrials.gov) | February 20, 2018 | 2/5/2017 | Treatment of IgA Nephropathy According to Renal Lesions | Treatment of IgA Nephropathy According to Renal Lesions | IgA Nephropathy | Drug: corticotherapy;Drug: Renin Angiotensin system (RAS) blockade | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 122 | Phase 3 | France |
| 131 | EUCTR2017-000891-27-SE (EUCTR) | 19/02/2018 | 17/10/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden;Hungary;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;Jordan;France;India;Italy;Colombia;Israel;Lebanon;Spain;Thailand;Hong Kong;Taiwan;Philippines;United States | ||
| 132 | NCT03608033 (ClinicalTrials.gov) | February 16, 2018 | 21/6/2018 | Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy | 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) | IgA Nephropathy | Biological: OMS721;Other: Vehicle (D5W or saline) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 450 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Hungary;Lithuania;Poland;Slovakia;Spain |
| 133 | NCT03373461 (ClinicalTrials.gov) | February 7, 2018 | 30/11/2017 | Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation | An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | IgA Nephropathy | Drug: LNP023;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 112 | Phase 2 | Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;India;Israel;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Hungary;Italy;Spain;United States |
| 134 | NCT03453619 (ClinicalTrials.gov) | January 22, 2018 | 27/2/2018 | Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies | A 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 Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 135 | EUCTR2017-000891-27-FI (EUCTR) | 09/01/2018 | 23/11/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 136 | ChiCTR-IIR-17013487 | 2018-01-01 | 2017-11-22 | A multicenter, double blind, double dummy, randomized controlled clinical study on the treatment of IgA nephropathy with Zhengqingfengtongning extantab | A multicenter, double blind, double dummy, randomized controlled clinical study on the treatment of IgA nephropathy with Zhengqingfengtongning extantab | IgA nephropathy | Experimental 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 University | NULL | Recruiting | 18 | 70 | Both | Experimental group:36;Control group 1:36;Control group 2:36; | 4 (Phase 4 study) | China |
| 137 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |
| 138 | NCT03633864 (ClinicalTrials.gov) | November 22, 2017 | 7/8/2018 | Fecal Microbiota Transplantation for Refractory IgA Nephropathy | Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study | IgA Nephropathy | Biological: Fecal microbiota transplantation | Air Force Military Medical University, China | NULL | Unknown status | 18 Years | 65 Years | All | 30 | Phase 2 | China |
| 139 | EUCTR2017-000891-27-GB (EUCTR) | 21/11/2017 | 06/10/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 140 | EUCTR2016-002262-31-GB (EUCTR) | 17/03/2017 | 27/01/2017 | A 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of | ||
| 141 | JPRN-JapicCTI-183956 | 21/2/2017 | 14/05/2018 | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy | Intervention 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. | NULL | complete | 20 | BOTH | 60 | Phase 2 | Japan, Europe | |
| 142 | NCT02808429 (ClinicalTrials.gov) | January 31, 2017 | 16/6/2016 | Efficacy and Safety of Atacicept in IgA Nephropathy | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy | Drug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States;Japan;United Kingdom;Germany |
| 143 | EUCTR2016-004507-31-FR (EUCTR) | 27/01/2017 | 02/02/2017 | N/A | N/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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 122 | Phase 3 | France | ||
| 144 | ChiCTR-IOR-16010174 | 2016-12-01 | 2016-12-16 | Clinical Study on Treatment of spleen and kidney Yang deficiency type of IgA nephropathy proteinuria with 'Huangqi guizhi wuwu' decoction | Clinical Study on Treatment of spleen and kidney Yang deficiency type of IgA nephropathy proteinuria with 'Huangqi guizhi wuwu' decoction | IgA nephropathy | Basic 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 TCM | NULL | Recruiting | 18 | 65 | Both | Basic treatment+Valsartan Capsules treatment group:50;Basic treatment+Huangqi guizhi wuwu decoction treatment group:50; | China | |
| 145 | NCT03218852 (ClinicalTrials.gov) | December 2016 | 7/12/2016 | Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy | IgA Nephropathy | Drug: prednisone and cyclophosphamide;Drug: prednisone alone | Guangdong General Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | All | 133 | Phase 4 | China |
| 146 | NCT02942381 (ClinicalTrials.gov) | September 13, 2016 | 14/10/2016 | A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy | IgA Patients;Hydroxychloroquine | Drug: Hydroxychloroquine Sulfate;Drug: Placebo | Peking University First Hospital | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | China | |
| 147 | NCT02981212 (ClinicalTrials.gov) | June 2016 | 24/11/2016 | Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy | Multi-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 Nephropathy | IgA Nephropathy | Drug: Mycophenolate Mofetil;Drug: ACE inhibitor;Drug: Corticosteroid;Drug: ARB | Yonsei University | Chong 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 Hospital | Recruiting | 19 Years | 65 Years | Both | 100 | Phase 4 | Korea, Republic of |
| 148 | NCT02765594 (ClinicalTrials.gov) | June 2016 | 30/4/2016 | Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy | Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study | Primary IgA Nephropathy | Drug: Hydroxychloroquine Sulfate;Drug: Valsartan | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 60 Years | All | 98 | Phase 4 | China |
| 149 | NCT02712697 (ClinicalTrials.gov) | June 2016 | 17/11/2015 | Integrative Medicine of IgA Nephropathy | Treatment 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 Trial | Primary IgA Nephropathy | Drug: WM (Shentong Granules);Drug: Hormone (prednisone) | Shanghai University of Traditional Chinese Medicine | RenJi Hospital;Ruijin Hospital;Shanghai 6th People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Fudan University | Not yet recruiting | 18 Years | 70 Years | Both | 140 | N/A | China |
| 150 | NCT02662283 (ClinicalTrials.gov) | May 2016 | 20/1/2016 | Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy | Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical Trial | IGA Nephropathy | Drug: Prednisolone;Drug: Reh-acteoside | Sun Yat-sen University | NULL | Not yet recruiting | 14 Years | 70 Years | Both | 75 | Phase 2/Phase 3 | China |
| 151 | NCT02647255 (ClinicalTrials.gov) | March 2016 | 21/12/2015 | Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy | Randomized 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 Glomerulonephritis | Procedure: Plasma Exchange (PE);Drug: Methylprednisolone pulse | Peking University First Hospital | NULL | Terminated | 14 Years | 65 Years | All | 10 | Phase 2/Phase 3 | China |
| 152 | NCT02682407 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 | A 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 Disease | IgAN;Lupus Nephritis;MN;C3 Glomerulopathy | Biological: OMS721 (narsoplimab) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | United States;Hong Kong |
| 153 | NCT03015974 (ClinicalTrials.gov) | January 2016 | 3/1/2017 | Registry of IgA Nephropathy in Chinese Children | Registry of IgA Nephropathy in Chinese Children | IgA Nephropathy;Proteinuria in Nephrotic Range;Immunosuppressive Treatment | Drug: Corticosteroid;Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Dipyridamole;Drug: ACE Inhibitor or Angiotensin receptor antagonist | Peking University First Hospital | Nanjing 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 Yunnan | Recruiting | 1 Month | 18 Years | All | 1200 | China | |
| 154 | NCT02605525 (ClinicalTrials.gov) | December 31, 2015 | 12/11/2015 | Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy | A 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 Nephropathy | Biological: SM101;Other: Placebo | Baxalta now part of Shire | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | NULL |
| 155 | EUCTR2015-002345-64-CZ (EUCTR) | 12/11/2015 | 08/09/2015 | Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2 | United States;Hong Kong;Czech Republic;Canada;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 156 | NCT02433236 (ClinicalTrials.gov) | September 2015 | 29/4/2015 | Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy | A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050 | IGA Nephropathy | Drug: Fostamatinib Disodium tablet 100 mg;Drug: Fostamatinib Disodium tablet 150 mg | Rigel Pharmaceuticals | NULL | Withdrawn | 18 Years | 72 Years | Both | 0 | Phase 2 | NULL |
| 157 | ChiCTR-IPR-15006760 | 2015-08-07 | 2015-07-16 | Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study | Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study | IgA nephropathy | Tacrolimus Group :Tacrolimus;Glucocorticoids Group :Glucocorticoids; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Pending | 18 | 65 | Both | Tacrolimus Group :90;Glucocorticoids Group :90; | China | |
| 158 | EUCTR2014-001365-26-IT (EUCTR) | 05/06/2015 | 23/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Portugal;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 | ||
| 159 | EUCTR2014-001365-26-ES (EUCTR) | 27/05/2015 | 27/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Portugal;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 | ||
| 160 | EUCTR2014-001365-26-SE (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;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 | ||
| 161 | EUCTR2014-001365-26-HU (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;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 | ||
| 162 | NCT02282930 (ClinicalTrials.gov) | March 2015 | 31/10/2014 | Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression | An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression | Progressive IgA Nephropathy;Proteinuria | Drug: ACTH (Acthar) Gel | Mayo Clinic | Mallinckrodt | Completed | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 163 | EUCTR2014-003402-33-SE (EUCTR) | 12/02/2015 | 29/12/2014 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Sweden | ||
| 164 | EUCTR2014-003402-33-BE (EUCTR) | 09/02/2015 | 11/12/2014 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Sweden | ||
| 165 | EUCTR2014-001365-26-DE (EUCTR) | 02/02/2015 | 07/08/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Belarus;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 | ||
| 166 | NCT02382523 (ClinicalTrials.gov) | February 2015 | 9/1/2015 | Acthar on Proteinuria in IgA Nephropathy Patients | Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria | IgA Nephropathy;Proteinuria | Drug: Acthar 80 unit injection | Baylor College of Medicine | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | United States |
| 167 | NCT02351752 (ClinicalTrials.gov) | January 2015 | 27/1/2015 | Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study | Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease | Primary IgA Nephropathy | Drug: Hydroxychloroquine Sulfate | LLiu | NULL | Completed | 18 Years | 75 Years | Both | 20 | Phase 4 | China |
| 168 | NCT02052219 (ClinicalTrials.gov) | October 2014 | 29/1/2014 | BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 169 | NCT02112838 (ClinicalTrials.gov) | October 2014 | 10/4/2014 | Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy | A 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 | IGA Nephropathy | Drug: Fostamatinib 150 mg;Drug: Fostamatinib 100 mg;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 76 | Phase 2 | United States;Austria;Germany;Hong Kong;Taiwan;United Kingdom;Singapore;Switzerland |
| 170 | NCT02231125 (ClinicalTrials.gov) | September 2014 | 30/8/2014 | Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy | Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial | IgA Nephropathy | Drug: Losartan;Drug: Abelmoschus manihot | Chen Xiangmei | Jiangsu Suzhong Pharmaceutical Group Co., Ltd. | Recruiting | 18 Years | 65 Years | Both | 1600 | Phase 4 | China |
| 171 | EUCTR2014-000331-16-AT (EUCTR) | 25/08/2014 | 22/07/2014 | N/A | A 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hong Kong;Taiwan;Singapore;Austria;United Kingdom;Switzerland | ||
| 172 | EUCTR2014-001365-26-CZ (EUCTR) | 21/08/2014 | 22/05/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of | ||
| 173 | EUCTR2014-000331-16-GB (EUCTR) | 28/07/2014 | 08/05/2014 | N/A | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom | ||
| 174 | NCT02187900 (ClinicalTrials.gov) | June 2014 | 22/6/2014 | Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f. | Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f | IgA Nephropathy | Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH);Drug: Mycophenolate mofetil (MMF) | Second Xiangya Hospital of Central South University | NULL | Recruiting | 16 Years | 65 Years | Both | 300 | Phase 3 | China |
| 175 | NCT02160132 (ClinicalTrials.gov) | June 2014 | 3/6/2014 | A 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 Nephropathy | Drug: Methylprednisolone(intravenously in the 1st-2nd-3rd month );Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month) | Sun Yat-sen University | NULL | Recruiting | 14 Years | 65 Years | Both | 180 | Phase 2 | China |
| 176 | NCT01854814 (ClinicalTrials.gov) | July 2013 | 9/5/2013 | The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients | The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study | IgA Nephropathy | Drug: Mycophenolate mofetil;Drug: Losartan | Fan Fan Hou | NULL | Recruiting | 16 Years | 70 Years | All | 232 | N/A | China |
| 177 | NCT02062684 (ClinicalTrials.gov) | June 2013 | 12/2/2014 | BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 57 | Phase 2/Phase 3 | Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain |
| 178 | EUCTR2012-001923-11-ES (EUCTR) | 09/01/2013 | 29/11/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 179 | ChiCTR-TRC-13003038 | 2013-01-01 | 2013-01-11 | Mizoribine for the Treatment of Pediatric IgA Nephropathy | Mizoribine for the Treatment of Pediatric IgA Nephropathy with Moderate Proteinuria--An open, prospective, random, multicenter study | IgA nephropathy | MZR: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 Hospital | NULL | Completed | 6 | 18 | Both | MZR:60;CVT:60; | China | |
| 180 | NCT01781312 (ClinicalTrials.gov) | January 2013 | 16/1/2013 | Probiotics in IgA Nephropathy | Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients | IgA Nephropathy | Dietary Supplement: ProTectis;Dietary Supplement: Gastrus | Uppsala University Hospital | University Hospital, Linkoeping;Karolinska Institutet | Not yet recruiting | 18 Years | N/A | Both | 20 | N/A | Sweden |
| 181 | EUCTR2012-001923-11-NL (EUCTR) | 18/12/2012 | 19/10/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 182 | EUCTR2012-001923-11-DE (EUCTR) | 10/12/2012 | 22/08/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 183 | NCT01758120 (ClinicalTrials.gov) | December 2012 | 12/12/2012 | Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | IgA Nephropathy | Drug: prednisone plus cyclophosphamide;Drug: Prednisone alone | Guangdong General Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | All | 135 | Phase 4 | China |
| 184 | NCT01738035 (ClinicalTrials.gov) | December 2012 | 25/7/2012 | The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease | A 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 Disease | Primary IgA Nephropathy | Drug: NEFECON;Other: Placebo | Pharmalink AB | NULL | Completed | 18 Years | N/A | Both | 150 | Phase 2 | Belgium;Czech Republic;Denmark;Finland;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 185 | EUCTR2012-001923-11-SE (EUCTR) | 21/11/2012 | 03/09/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 186 | EUCTR2012-001923-11-BE (EUCTR) | 19/11/2012 | 22/08/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 187 | EUCTR2012-001923-11-GB (EUCTR) | 06/11/2012 | 28/09/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 188 | EUCTR2012-001923-11-DK (EUCTR) | 05/11/2012 | 14/09/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 189 | EUCTR2012-001923-11-CZ (EUCTR) | 24/10/2012 | 16/08/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 190 | EUCTR2012-001923-11-FI (EUCTR) | 17/10/2012 | 15/08/2012 | A 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 disease | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 191 | EUCTR2012-001923-11-IT (EUCTR) | 27/09/2012 | 24/09/2012 | A 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 disease | A 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 OY | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 192 | ChiCTR-TRC-12002228 | 2012-06-15 | 2012-02-03 | The Clinical Study on the Dispelling Wind-dampness of IgA Nephropathy | The 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 Nephropathy | Treatment group:IgA nephropathy side (granules)+TWP tablet;Control group:Chinese medicine simulation granules + The Tripterygium simulation piece; | Hangzhou Hospital of Traditional Chinese Medicine | NULL | Completed | 16 | 65 | Both | Treatment group:114;Control group:114; | China | |
| 193 | NCT01560052 (ClinicalTrials.gov) | May 5, 2012 | 15/3/2012 | Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) | Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study | IgA Glomerulonephritis | Drug: methylprednisolone;Drug: Placebo | The George Institute | Peking University First Hospital | Completed | 18 Years | N/A | All | 503 | N/A | Australia;Canada;China;Hong Kong;India;Malaysia |
| 194 | NCT02526966 (ClinicalTrials.gov) | March 2012 | 17/8/2015 | Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy | Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy | IgA Nephropathy | Biological: blood sample | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 68 | N/A | France |
| 195 | NCT02571842 (ClinicalTrials.gov) | January 2012 | 6/10/2015 | Rituximab in Recurrent IgA Nephropathy | A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology | Recurrent IgA Nephropathy | Drug: Intravenous Rituximab;Drug: ACEI/ARB and corticosteroids | Chulalongkorn University | NULL | Recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Thailand |
| 196 | NCT01451710 (ClinicalTrials.gov) | March 2011 | 7/10/2011 | The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy | The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy | IgA Nephropathy | Drug: Prednisone or Prednisolone | Nanjing University School of Medicine | NULL | Completed | 18 Years | 65 Years | Both | 30 | N/A | China |
| 197 | NCT01237028 (ClinicalTrials.gov) | March 2011 | 8/11/2010 | Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers | Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers | IgA Nephropathy | Drug: Calcitriol | Yonsei University | NULL | Completed | 20 Years | 70 Years | Both | 168 | N/A | Korea, Republic of |
| 198 | NCT02523768 (ClinicalTrials.gov) | January 8, 2011 | 4/8/2015 | Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment | Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment | Glomerulonephritis;IgAN | Drug: ATG-F;Drug: Simulect | Centre Hospitalier Universitaire de Saint Etienne | NULL | Terminated | 18 Years | 75 Years | All | 117 | Phase 4 | France |
| 199 | ChiCTR-OPN-16010028 | 2011-01-01 | 2016-11-23 | Effects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuria | Effects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuria | IgA nephropathy | Prednisone (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 Hospital | NULL | Completed | 21 | 54 | Both | Prednisone (PRE) group:10;conventional-dose TW (CTW) group:10;double-dose TW (DTW) group:10; | NULL | |
| 200 | ChiCTR-ONC-10001124 | 2011-01-01 | 2010-12-04 | The effect and safety of mizoribine for IgA Nephropathy in children | The effect and safety of mizoribine for IgA Nephropathy in children | IgA nephropathy | 1:mizoribine 3~5mg/kg.d; | Nanjing general hospital of Nanjing military command | NULL | Completed | 5 | 16 | Both | 1:30; | China | |
| 201 | NCT01224028 (ClinicalTrials.gov) | November 2010 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients | Double-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 Nephropathy | IgA Nephropathy | Drug: Tacrolimus;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 18 Years | 70 Years | Both | 40 | Phase 2 | Korea, Republic of |
| 202 | NCT01269021 (ClinicalTrials.gov) | November 2010 | 10/12/2010 | An 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 dose | Zhi-Hong Liu, M.D. | NULL | Completed | 18 Years | 60 Years | Both | 176 | N/A | China |
| 203 | NCT01203007 (ClinicalTrials.gov) | September 2010 | 15/9/2010 | Diet Intervention in Food Sensitive Patients With IgA Nephropathy | A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy | IGA Nephropathy | Dietary Supplement: Tailored diet;Dietary Supplement: Low antigen content diet | Uppsala University Hospital | University Hospital, Linkoeping;Haukeland University Hospital;Smerud Medical Research International AS | Not yet recruiting | 18 Years | N/A | Both | 40 | N/A | Norway;Sweden |
| 204 | NCT01103778 (ClinicalTrials.gov) | July 2010 | 13/4/2010 | Pilot Study of Velcade® in IgA Nephropathy | Velcade Therapy for Severe IgA Nephropathy | Chronic Kidney Disease;IgA Nephropathy | Drug: Bortezomib (Velcade®) | The Rogosin Institute | Weill Medical College of Cornell University | Completed | 18 Years | N/A | All | 11 | Phase 4 | United States |
| 205 | NCT01184599 (ClinicalTrials.gov) | June 2010 | 16/8/2010 | A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy | Glomerulonephritis, IGA;Hypertension | Drug: aliskiren | Kagawa University | NULL | Recruiting | 16 Years | 75 Years | Both | 30 | Phase 4 | Japan | |
| 206 | EUCTR2009-016003-26-GB (EUCTR) | 06/05/2010 | 17/03/2010 | RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic | RANDOMISED 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United Kingdom | ||
| 207 | ChiCTR-TRC-10000776 | 2010-02-27 | 2010-02-10 | A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy | A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy | lgA nephropathy;ICD:N03.8 | 1:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide; | Chinese General Hospital of PLA | NULL | Completed | 18 | 55 | Both | 1:100;2:100;3:100;4:100; | China | |
| 208 | ChiCTR-TRC-13003702 | 2010-01-01 | 2013-10-12 | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropathy | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropathy | IgA Nephropathy | Experimental 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 Medicine | NULL | Completed | 18 | 60 | Both | Experimental Group:100;Placebo Comparator:10; | China | |
| 209 | ChiCTR-TRC-10000824 | 2010-01-01 | 2010-04-06 | the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | Multicenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | IgA Nephropathy | the 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 College | NULL | Completed | 18 | 65 | Both | the control group:60;the treatment group:60; | China | |
| 210 | NCT01879514 (ClinicalTrials.gov) | January 2010 | 25/3/2013 | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | IgA Nephropathy | Drug: Chinese Herb Prescription Granule plus prednisone;Drug: Placebo | Shanghai University of Traditional Chinese Medicine | Shanghai Sixth People's Hospital;RenJi Hospital | Recruiting | 18 Years | 60 Years | Both | 200 | N/A | China |
| 211 | JPRN-UMIN000002887 | 2009/12/01 | 14/12/2009 | A 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 nephropathy | statin 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 Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not selected | Japan | |
| 212 | NCT01129557 (ClinicalTrials.gov) | September 2009 | 21/5/2010 | Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease | Aldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease | Proteinuric Kidney Disease;Diabetic Nephropathy;Hypertensive Nephrosclerosis;IgA Nephropathy;Focal Segmental Glomerulosclerosis;Glomerulopathy (Obesity-associated);Glomerulonephritis, Membranous | Drug: Aliskiren;Drug: Valsartan | Columbia University | Novartis Pharmaceuticals | Terminated | 18 Years | N/A | All | 46 | Phase 4 | United States |
| 213 | NCT00922311 (ClinicalTrials.gov) | July 2009 | 14/6/2009 | Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade | Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study | IgA Nephropathy | Drug: Aliskiren | The University of Hong Kong | Queen Mary Hospital, Hong Kong;United Christian Hospital | Completed | 18 Years | 70 Years | Both | 25 | Phase 4 | China |
| 214 | ChiCTR-TRC-09000338 | 2009-04-01 | 2009-02-23 | Full dose of RASS blockade versus steroids therapy in patients with IgA nephropathy | Full dose of RASS blockade versus steroids therapy in patients with IgA nephropathy | IgA nephropathy | Group A:Full dose of RASS blockade (ACEI and ARB blocker);Group B:prednisone ; | The First Affiliated Hospital of Zhejiang University | NULL | Completed | 18 | 70 | Male | Group A:60;Group B:60; | China | |
| 215 | NCT00870493 (ClinicalTrials.gov) | April 2009 | 26/3/2009 | Aliskiren for Immunoglobulin A (IgA) Nephropathy | The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study | IgA Nephropathy | Drug: Aliskiren;Drug: Placebo | Chinese University of Hong Kong | NULL | Completed | 18 Years | 65 Years | Both | 22 | Phase 3 | Hong Kong |
| 216 | NCT00856674 (ClinicalTrials.gov) | March 2009 | 4/3/2009 | Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy | A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous OPL-CCL2-LPM in Patients With IgA Nephropathy | IGA Nephropathy;Proteinuria | Biological: OPL-CCL2-LPM | Osprey Pharmaceuticals USA, Inc. | NULL | Terminated | 18 Years | N/A | Both | 30 | Phase 1 | Canada |
| 217 | NCT00885547 (ClinicalTrials.gov) | March 2009 | 20/4/2009 | Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis | Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis. | IgA Nephropathy | Drug: tripterygium wilfordii (TW) | Nanjing University School of Medicine | NULL | Terminated | 18 Years | 60 Years | Both | 90 | N/A | China |
| 218 | NCT00498368 (ClinicalTrials.gov) | February 2009 | 9/7/2007 | Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy | A Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy | IgA Nephropathy | Drug: Intravenous Rituximab;Drug: ACE/ARB;Dietary Supplement: Omega-3 Fatty Acid Fish Oil Supplement | Mayo Clinic | Ohio State University;Stanford University;University of North Carolina, Chapel Hill;Columbia University;Genentech, Inc.;Biogen | Completed | 18 Years | 70 Years | All | 34 | Phase 4 | United States |
| 219 | ChiCTR-TRC-09000607 | 2008-12-01 | 2009-11-28 | Observation for Efficacy of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathy | Efficacy Observation of methylprednisolone and combined therapy of methylprednisolone and mycophenolate mofetil for IgA nephropathy | IgA nephropathy | A: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 University | NULL | Completed | 18 | 70 | Both | A:40;B:40; | China | |
| 220 | EUCTR2007-000443-99-DE (EUCTR) | 09/04/2008 | 13/11/2008 | 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 | 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 Ulm | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 221 | NCT00554502 (ClinicalTrials.gov) | February 2008 | 29/10/2007 | Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy | Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy | IgA Nephropathy | Drug: supportive therapy with: ACE-inhibitor / ARB / Statin;Drug: supportive and immunosuppressive therapy | RWTH Aachen University | NULL | Completed | 18 Years | 70 Years | Both | 148 | Phase 3 | Germany |
| 222 | EUCTR2007-000871-41-DE (EUCTR) | 24/01/2008 | 27/11/2007 | Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN | Supportive 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 Aachen | NULL | Not Recruiting | Female: yes Male: yes | 148 | Germany | |||
| 223 | NCT00599963 (ClinicalTrials.gov) | January 2008 | 2/1/2008 | Paricalcitol for the Treatment of Immunoglobulin A Nephropathy | Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study | IgA Nephropathy | Drug: paricalcitol | Chinese University of Hong Kong | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 3 | Hong Kong;China |
| 224 | NCT00549692 (ClinicalTrials.gov) | November 2007 | 25/10/2007 | Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy | Minimization, 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 Nephropathy | IgA Nephropathy | Drug: Omega-3 fatty acid ethylester90 | Kuhnil Pharmaceutical Co., Ltd. | Pronova BioPharma ASA | Completed | 18 Years | N/A | Both | 152 | Phase 3 | Korea, Republic of |
| 225 | NCT00657059 (ClinicalTrials.gov) | September 2007 | 8/4/2008 | Mycophenolate 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 Nephropathy | Drug: irbesartan;Drug: methylprednisolone (MP) or prednisone (pred);Drug: mycophenolate mofetil (MMF) | Sun Yat-sen University | NULL | Completed | 14 Years | 60 Years | All | 151 | Phase 3 | China |
| 226 | NCT00793585 (ClinicalTrials.gov) | July 2007 | 17/11/2008 | A Controlled Study of Uric Acid on the Progression of IgA Nephropathy | A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy | IgA Nephropathy | Drug: allopurinol;Other: continue their usual therapy | Sun Yat-sen University | NULL | Completed | 18 Years | 70 Years | All | 40 | N/A | China |
| 227 | NCT00426348 (ClinicalTrials.gov) | May 2007 | 23/1/2007 | A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | Glomerulonephritis;IGA Nephropathy | Drug: Valsartan;Drug: Probucol;Drug: Placebo | Guangdong General Hospital | NULL | Completed | 18 Years | 60 Years | Both | 75 | Phase 4 | China |
| 228 | JPRN-UMIN000002474 | 2007/01/01 | 01/10/2009 | Preventive 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 nephropathy | Menatetrenone 45mg/day for 6 months Calcitriol 0.5 microgram/day for 6 months Risedronate 17.5mg/week for 6 months | Osaka University HospitalDepartment of nephrology | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 229 | JPRN-UMIN000000593 | 2006/11/01 | 05/02/2007 | Randomized controlled trial of mizoribine for progressive IgA nephropathy | IgA nephropathy with moderate to severe histological alterations | Methylprednisolone 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 Nephropathy | NULL | Complete: follow-up complete | 15years-old | 60years-old | Male and Female | 120 | Not selected | Japan | |
| 230 | NCT00319761 (ClinicalTrials.gov) | May 2006 | 27/4/2006 | Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy | The Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A Nephropathy | IGA Nephropathy | Drug: Calcitriol | Chinese University of Hong Kong | NULL | Completed | 18 Years | 65 Years | Both | 10 | Phase 4 | Hong Kong |
| 231 | ChiCTR-TRC-06000004 | 2006-01-01 | 2006-09-14 | ACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trial | ACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trial | primary IgA nephropathy | group 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 University | NULL | Completed | 16 | 65 | Both | group 1:78;group 2:78; | China | |
| 232 | NCT00396721 (ClinicalTrials.gov) | January 2006 | 3/11/2006 | Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy | Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus. | Glomerulonephritis, IGA;Nephropathy, IGA;IGA Nephropathy | Drug: ACE inhibitor + statin;Drug: Sirolimus (study drug)+ACE inhibitor + statin | Josep m Cruzado | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | 18 Years | 70 Years | Both | 23 | Phase 2 | Spain |
| 233 | NCT00378443 (ClinicalTrials.gov) | January 2006 | 19/9/2006 | ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT | Glomerulonephritis, IGA | Drug: prednisone + Inhibace/Cozaar;Drug: Inhibace/Cozaar | Peking University | NULL | Active, not recruiting | 16 Years | 65 Years | Both | N/A | NULL | ||
| 234 | EUCTR2005-002610-37-ES (EUCTR) | 05/12/2005 | 30/09/2005 | PILOT 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 | PILOT 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Spain | |||
| 235 | EUCTR2005-003885-40-IT (EUCTR) | 18/10/2005 | 15/01/2007 | ACE-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 LECCO | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 236 | NCT00767221 (ClinicalTrials.gov) | October 2005 | 5/10/2008 | Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study | Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study | IGA Nephropathy | Drug: Budesonide | Pharmalink AB | Archimedes Development Ltd | Completed | 18 Years | N/A | Both | 20 | Phase 2 | Sweden |
| 237 | JPRN-C000000006 | 2005/01/01 | 01/08/2005 | Lisinopril 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 children | Lisinopril for 2 years Lisinopril+losartan for 2 years | Japanese Study group of Kidney Disease in Children | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 110 | Not selected | Japan | |
| 238 | JPRN-C000000341 | 2004/04/01 | 31/03/2006 | Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy | Refractory IgA nephropathy | Prednisolone 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 IgAN | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 60 | Not selected | Japan | |
| 239 | ChiCTR-TRC-09000630 | 2004-01-01 | 2005-09-06 | Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial | Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial | IgA nephropathy | Two groups:ramipril 5 years versus no treatment; | The Chinese University of Hong Kong | NULL | Recruiting | 0 | 0 | Male | Two groups:60; | China | |
| 240 | JPRN-C000000380 | 2003/04/01 | 31/03/2006 | The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial | IgA nephropathy | ARB valsartan ACE-I enalapril | ARB therapeutic society of IgA nephropathy | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 400 | Phase 4 | Japan | |
| 241 | NCT00301600 (ClinicalTrials.gov) | January 2003 | 10/3/2006 | Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy | Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy | IGA Nephropathy | Drug: Mycophenolate mofetil | Nanjing University School of Medicine | NULL | Completed | 12 Years | 65 Years | Both | 40 | N/A | China |
| 242 | NCT01225445 (ClinicalTrials.gov) | April 2002 | 20/10/2010 | Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial | Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial | Biopsy-confirmed IgA Nephropathy;Proteinuria Less Than 0.5 g Per Day;Normal Blood Pressure;Serum Creatinine Below 120 Umol/l | Drug: Ramipril | Chinese University of Hong Kong | NULL | Completed | 18 Years | 25 Years | Both | 60 | Phase 3 | Hong Kong |
| 243 | NCT00863252 (ClinicalTrials.gov) | March 2002 | 15/3/2009 | Mycophenolate Mofetil for IgA Nephropathy | A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade | IGA Nephropathy | Drug: mycophenolate mofetil;Drug: angiotensin blockade | The University of Hong Kong | United Christian Hospital;Queen Mary Hospital, Hong Kong | Completed | 18 Years | 70 Years | Both | 40 | Phase 4 | China |
| 244 | NCT00318474 (ClinicalTrials.gov) | January 2002 | 24/4/2006 | Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy | A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy | IgA Nephropathy | Drug: Mycophenolate Mofetil (MMF);Drug: MMF Placebo;Drug: ACEi;Drug: FOS | St. Joseph's Hospital and Medical Center, Phoenix | NULL | Terminated | 7 Years | 70 Years | All | 184 | Phase 3 | United States |
| 245 | JPRN-C000000363 | 2001/08/01 | 14/05/2007 | A 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 children | prednisolone+mizoribine for 2 years prednisolone+mizoribine+warfarin+dipyridamole for 2 years | The Japanese Pediatric IgA Nephropathy ofTreatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 80 | Not selected | Japan | |
| 246 | NCT00006137 (ClinicalTrials.gov) | May 2000 | 3/8/2000 | Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy | IGA Glomerulonephritis | Drug: enalapril | National Center for Research Resources (NCRR) | Stanford University | Completed | 13 Years | 60 Years | Both | 43 | N/A | NULL | |
| 247 | NCT01392833 (ClinicalTrials.gov) | December 1999 | 5/7/2011 | Steroids and Azathioprine in Advanced IgAN | Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial | IgA Nephropathy;Chronic Kidney Disease | Drug: methylprednisolone;Drug: azathioprine;Drug: prednisone | A. Manzoni Hospital | NULL | Completed | 16 Years | 70 Years | Both | 46 | Phase 3 | NULL |
| 248 | JPRN-C000000375 | 1998/08/01 | 01/04/2006 | A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children. | IgA nephropathy in children | prednisolone+mizoribine+warfarin+dipyridamole for 2 years | The Japanese Pediatric IgA Nephropathy of Treatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 20 | Not selected | Japan | |
| 249 | JPRN-C000000373 | 1998/08/01 | 01/04/2006 | Lisinopril for IgA nephropathy with focal mesangial proliferation in children | IgA nephropathy in children | Lisinopril for 2 years | The Japanese Pediatric IgA Nephropathy of Treatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 50 | Not selected | Japan | |
| 250 | JPRN-C000000374 | 1998/08/01 | 01/04/2006 | A combination of prednisolone, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial proliferation in children. | IgA nephropathy in children | prednisolone+warfarin+dipyridamole for 2 years | The Japanese Pediatric IgA Nephropathy ofTreatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 20 | Not selected | Japan | |
| 251 | NCT00755859 (ClinicalTrials.gov) | May 1998 | 18/9/2008 | Steroids and Azathioprine Versus Steroids Alone in IgAN | Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. | IGA Nephropathy | Drug: steroids plus azathioprine;Drug: steroids | A. Manzoni Hospital | NULL | Completed | 16 Years | 70 Years | Both | 206 | Phase 4 | Italy;Switzerland |
| 252 | NCT00367562 (ClinicalTrials.gov) | January 1996 | 22/8/2006 | Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy | Phase 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 Nephropathy | IGA Nephropathy | Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE | Hospital Britanico | NULL | Completed | 21 Years | 70 Years | Both | 20 | Phase 4 | Argentina |
| 253 | EUCTR2021-000621-27-NL (EUCTR) | 14/12/2021 | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 254 | EUCTR2021-000621-27-PL (EUCTR) | 01/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 255 | EUCTR2021-000621-27-DE (EUCTR) | 08/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden |