222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details
臨床試験数 : 285 / 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191
| No. | 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 | NCT05267262 (ClinicalTrials.gov) | March 15, 2022 | 23/2/2022 | Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis | A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGC | Alport Syndrome;Focal Segmental Glomerulosclerosis | Drug: R3R01 | River 3 Renal Corp. | IQVIA Biotech | Not yet recruiting | 12 Years | N/A | All | 50 | Phase 2 | NULL |
| 2 | 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 | ||
| 3 | NCT04983888 (ClinicalTrials.gov) | November 17, 2021 | 21/7/2021 | Obinutuzumab in Primary FSGS | A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids | Primary Focal Segmental Glomerulosclerosis | Drug: Obinutuzumab | Mayo Clinic | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 4 | NCT05162066 (ClinicalTrials.gov) | October 29, 2021 | 26/11/2021 | BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW) | An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMN | Complement 3 Glomerulopathy;Immunoglobulin A Nephropathy;Membranous Nephropathy | Drug: BCX9930 | BioCryst Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 42 | Phase 2 | Italy;Spain |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | NCT05003986 (ClinicalTrials.gov) | August 12, 2021 | 29/7/2021 | Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular 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 | Focal Segmental Glomerulosclerosis;Minimal Change Disease;Immunoglobulin A Nephropathy;Immunoglobulin A-Associated Vasculitis;Alport Syndrome | Drug: Sparsentan | Travere Therapeutics, Inc. | NULL | Recruiting | 1 Year | 17 Years | All | 57 | Phase 2 | United States;Poland;Spain |
| 9 | ChiCTR2100048382 | 2021-07-01 | 2021-07-06 | Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial | Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial | Idiopathic membranous nephropathy | Experimental group:On the basis of ACEI/ARB, tripterygium wilfordii polyglycoside tablets were added;Control group:The original dose of ACEI/ARB was used for treatment; | Department of Nephrology, Sichuan Provincial People's Hospital | NULL | Recruiting | 18 | 65 | Both | Experimental group:18;Control group:18; | N/A | China |
| 10 | NCT04629248 (ClinicalTrials.gov) | June 25, 2021 | 27/10/2020 | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy | A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy | Primary Membranous Nephropathy | Drug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 3 | United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru |
| 11 | EUCTR2020-004176-18-ES (EUCTR) | 21/06/2021 | 09/02/2021 | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - The AFFINITY Study | Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Australia;United Kingdom;Korea, Republic of | ||
| 12 | EUCTR2020-002637-15-FR (EUCTR) | 09/06/2021 | 02/02/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy | ||
| 13 | EUCTR2020-004176-18-IT (EUCTR) | 08/06/2021 | 08/06/2021 | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study | Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan Product Code: [atrasentan] INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | CHINOOK THERAPEUTICS, U.S., Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Australia;United Kingdom;Italy;Korea, Republic of | ||
| 14 | EUCTR2020-003233-38-PL (EUCTR) | 13/04/2021 | 24/02/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY | Primary Membranous Nephropathy (pMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: RO5072759 INN or Proposed INN: OBINUTUZUMAB Other descriptive name: OBINUTUZUMAB/ GA101 Product Name: Tacrolimus Product Code: RO0485337 INN or Proposed INN: Tacrolimus Product Name: Tacrolimus Product Code: RO0485337 INN or Proposed INN: Tacrolimus | F.Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China | ||
| 15 | EUCTR2020-002637-15-IT (EUCTR) | 09/04/2021 | 04/06/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: [APL-2] INN or Proposed INN: Pegcetacoplan Trade Name: Prevenar 13 suspension for injection Product Name: Prevenar 13 suspension for injection Product Code: [na] INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg Trade Name: Pneumococcal polysaccharide vaccine Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial Product Code: [na] INN or Proposed INN: Pneumococcal Polysaccharide Vaccine Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States | ||
| 16 | EUCTR2020-003233-38-IT (EUCTR) | 06/04/2021 | 04/06/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa | Primary Membranous Nephropathy (pMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: [RO5072759] INN or Proposed INN: OBINUTUZUMAB Other descriptive name: OBINUTUZUMAB/ GA101 Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Adoport Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Prograf Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS Trade Name: Adoport Product Name: Tacrolimus Product Code: [RO0485337] INN or Proposed INN: TACROLIMUS | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China | ||
| 17 | EUCTR2020-002637-15-NL (EUCTR) | 29/03/2021 | 04/01/2021 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy | ||
| 18 | NCT04572854 (ClinicalTrials.gov) | February 23, 2021 | 29/9/2020 | Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN | An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN | C3G;IC-MPGN;Renal Transplant;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Dense Deposit Disease;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | Drug: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 19 | 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 |
| 20 | NCT04733040 (ClinicalTrials.gov) | January 20, 2021 | 18/1/2021 | Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) | Glomerulonephritis;Membranous Nephropathy;antiPLA2R Positive | Drug: MOR202 | MorphoSys AG | NULL | Recruiting | 18 Years | 80 Years | All | 22 | Phase 2 | Georgia;Germany;Greece;Korea, Republic of;Russian Federation;Taiwan;United Kingdom |
| 21 | EUCTR2019-000780-24-PL (EUCTR) | 07/01/2021 | 14/09/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of | ||
| 22 | EUCTR2020-002637-15-GB (EUCTR) | 22/12/2020 | 23/10/2020 | Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN | AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE | complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom | ||
| 23 | EUCTR2020-002985-15-DE (EUCTR) | 21/12/2020 | 31/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 24 | EUCTR2019-003607-35-CZ (EUCTR) | 26/11/2020 | 26/11/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan | ||
| 25 | EUCTR2019-003607-35-SK (EUCTR) | 12/11/2020 | 09/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 26 | EUCTR2019-003607-35-IT (EUCTR) | 03/11/2020 | 02/08/2021 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) - - | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: [PF-06730512] INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Czechia;Slovakia;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan | ||
| 27 | EUCTR2019-003607-35-DE (EUCTR) | 26/10/2020 | 02/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 28 | EUCTR2019-003607-35-PL (EUCTR) | 23/10/2020 | 20/10/2020 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan | ||
| 29 | EUCTR2020-002985-15-GR (EUCTR) | 22/10/2020 | 11/09/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 30 | EUCTR2020-002985-15-GB (EUCTR) | 12/10/2020 | 25/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 31 | NCT04183101 (ClinicalTrials.gov) | October 1, 2020 | 14/11/2019 | Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy | Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy | C3 Glomerulopathy;Membranoproliferative Glomerulonephritis;Complement Abnormality;Dense Deposit Disease;C3 Glomerulonephritis | Drug: Aliskiren;Drug: Enalapril | Region Skane | NULL | Recruiting | 6 Years | N/A | All | 30 | Phase 2 | Sweden |
| 32 | EUCTR2019-001212-29-DK (EUCTR) | 26/08/2020 | 09/06/2020 | Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndrome | Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome | Nephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications. MedDRA version: 21.1;Level: LLT;Classification code 10029167;Term: Nephrotic syndrome with lesion of membranous glomerulonephritis;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10029165;Term: Nephrotic syndrome in diseases classified elsewhere;System Organ Class: 100000004857;Therapeutic area: Not possible to specify | Trade Name: Fragmin INN or Proposed INN: Dalteparin Other descriptive name: Dalteparin Trade Name: Eliquis INN or Proposed INN: Apixaban Other descriptive name: Apixaban | Aarhus University Hospital, Henrik Birn | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 1;Phase 2 | Denmark | ||
| 33 | EUCTR2020-000185-42-FR (EUCTR) | 12/06/2020 | 26/05/2020 | Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | APOL1-mediated Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: VX-147 Product Code: VX-147 INN or Proposed INN: VX147 Other descriptive name: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;France;United Kingdom | ||
| 34 | NCT04340362 (ClinicalTrials.gov) | June 8, 2020 | 7/4/2020 | Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis | Glomerulosclerosis, Focal Segmental | Drug: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 2 | United States;France;Puerto Rico;United Kingdom |
| 35 | EUCTR2020-000185-42-GB (EUCTR) | 01/06/2020 | 23/03/2020 | Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. | APOL1-mediated Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: VX-147 Product Code: VX-147 INN or Proposed INN: VX147 Other descriptive name: VX-147 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | France;United States;United Kingdom | ||
| 36 | EUCTR2019-001734-34-NL (EUCTR) | 07/04/2020 | 22/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China | ||
| 37 | NCT04065438 (ClinicalTrials.gov) | January 1, 2020 | 20/8/2019 | Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 System | Treatment of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System | Focal Segmental Glomerulosclerosis | Device: LIPOSORBER® LA-15 | Kaneka Medical America LLC | NULL | Recruiting | 22 Years | 75 Years | All | 35 | N/A | United States |
| 38 | NCT04154787 (ClinicalTrials.gov) | November 23, 2019 | 8/10/2019 | Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy | A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: LNP023;Drug: Rituximab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 52 | Phase 2 | United States;Argentina;China;Czechia;France;Germany;India;Netherlands;Singapore;Spain;Taiwan;United Kingdom |
| 39 | EUCTR2019-001734-34-ES (EUCTR) | 12/11/2019 | 04/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Rituximab INN or Proposed INN: RITUXIMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 40 | EUCTR2019-001734-34-DE (EUCTR) | 30/10/2019 | 12/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Germany;Netherlands;China | ||
| 41 | EUCTR2019-000780-24-ES (EUCTR) | 25/10/2019 | 26/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands | ||
| 42 | EUCTR2019-001734-34-FR (EUCTR) | 23/10/2019 | 13/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 43 | NCT04145440 (ClinicalTrials.gov) | October 15, 2019 | 18/10/2019 | Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) | Glomerulonephritis, Membranous;antiPLA2R Positive | Drug: MOR202 | MorphoSys AG | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain |
| 44 | EUCTR2017-003022-32-PL (EUCTR) | 12/10/2019 | 20/08/2019 | An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage) | An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome | Primary Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CCX140-B INN or Proposed INN: not available yet | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 13 | Phase 2 | United Kingdom;Poland;Canada;France;United States | ||
| 45 | EUCTR2019-000780-24-IT (EUCTR) | 08/10/2019 | 22/01/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands;Italy | ||
| 46 | EUCTR2019-000780-24-NL (EUCTR) | 24/09/2019 | 03/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of | ||
| 47 | EUCTR2019-001734-34-GB (EUCTR) | 23/09/2019 | 07/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 48 | EUCTR2019-000780-24-FR (EUCTR) | 23/09/2019 | 15/10/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;European Union;Spain;Netherlands | ||
| 49 | EUCTR2017-002674-39-NL (EUCTR) | 30/01/2019 | 18/07/2018 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 50 | NCT03448692 (ClinicalTrials.gov) | October 15, 2018 | 22/2/2018 | A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) | Drug: PF-06730512 | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 44 | Phase 2 | United States;Canada;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Slovakia;Spain;United Kingdom |
| 51 | NCT03703908 (ClinicalTrials.gov) | October 1, 2018 | 24/7/2018 | A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome | An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome | Focal Segmental Glomerulosclerosis | Drug: CCX140-B | ChemoCentryx | NULL | Recruiting | 18 Years | N/A | All | 13 | Phase 2 | United States |
| 52 | EUCTR2017-002674-39-IT (EUCTR) | 03/08/2018 | 08/06/2021 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A | C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH0144471 compresse Product Code: ACH0144471 INN or Proposed INN: ACH-0144471 Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML Product Name: ACT-HIB Product Code: [ACT-HIB] Product Name: Bexsero Product Code: [Bexsero] Product Name: Menveo Product Code: [Menveo] Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE Product Name: Prevenar 13 Product Code: | ACHILLION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 53 | EUCTR2017-002674-39-BE (EUCTR) | 31/07/2018 | 16/05/2018 | A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Australia;Netherlands;Italy | ||
| 54 | EUCTR2016-003525-42-NL (EUCTR) | 26/06/2018 | 09/01/2018 | A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Australia;Netherlands | ||
| 55 | NCT03598036 (ClinicalTrials.gov) | June 21, 2018 | 14/6/2018 | Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis | An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: Voclosporin | Aurinia Pharmaceuticals Inc. | NULL | Terminated | 18 Years | 75 Years | All | 5 | Phase 2 | United States;Dominican Republic |
| 56 | NCT03459443 (ClinicalTrials.gov) | June 20, 2018 | 26/2/2018 | A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471 | An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471 | C3 Glomerulonephritis;C3 Glomerulopathy;Immune Complex Membranoproliferative Glomerulonephritis;IC-MPGN;Dense Deposit Disease | Drug: Danicopan | Alexion Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 22 | Phase 2 | United States;Australia;Belgium;Italy;Netherlands |
| 57 | NCT03422510 (ClinicalTrials.gov) | April 15, 2018 | 30/1/2018 | FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) | A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) | Primary Focal Segmental Glomerulosclerosis | Drug: CXA-10 | Complexa, Inc. | Kidney Research Network, formerly NephCure Accelerating Cures Institute;Medpace, Inc.;MicroConstants;Arkana Labs;NephCure Kidney International | Completed | 13 Years | N/A | All | 33 | Phase 2 | United States |
| 58 | NCT03285711 (ClinicalTrials.gov) | October 6, 2017 | 14/9/2017 | Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN) | A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN) | Lupus Membranous Nephropathy | Drug: Filgotinib;Drug: Lanraplenib;Drug: Filgotinib placebo;Drug: Lanraplenib placebo | Gilead Sciences | NULL | Completed | 18 Years | 75 Years | All | 9 | Phase 2 | United States |
| 59 | NCT03095118 (ClinicalTrials.gov) | September 7, 2017 | 20/3/2017 | Daratumumab in Treatment of PGNMID and C3 GN | Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy | Membranoproliferative Glomerulonephritis | Drug: Daratumumab | Fernando Fervenza | NULL | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 60 | NCT03124368 (ClinicalTrials.gov) | August 9, 2017 | 12/4/2017 | A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGN | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | C3 Glomerulonephritis;Dense Deposit Disease;Membranoproliferative Glomerulonephritis, Type II;C3 Glomerulopathy;Immune Complex Mediated Membranoproliferative Glomerulonephritis | Drug: ACH-0144471 | Alexion Pharmaceuticals | NULL | Completed | 16 Years | 65 Years | All | 6 | Phase 2 | Australia;Belgium;Netherlands |
| 61 | NCT02921789 (ClinicalTrials.gov) | May 22, 2017 | 30/9/2016 | Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | Kidney Transplantation;Focal Segmental Glomerulosclerosis (FSGS) | Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: Prednisone | Astellas Pharma Global Development, Inc. | Kyowa Kirin Co., Ltd. | Completed | 18 Years | N/A | All | 71 | Phase 2 | United States;Canada |
| 62 | EUCTR2013-000226-55-NL (EUCTR) | 04/03/2015 | 24/06/2014 | SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY | European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN | Primary membranous nephropathy MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Tacrolimus Product Name: TACROLIMUS INN or Proposed INN: TACROLIMUS Other descriptive name: TACROLIMUS Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE ACETATE Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Fundacion Renal Iñigo Alvarez Toledo | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 175 | Spain;Netherlands | |||
| 63 | NCT02235857 (ClinicalTrials.gov) | March 2015 | 6/9/2014 | Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children | Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System | Focal Segmental Glomerulosclerosis | Device: LIPOSORBER® LA-15 System | Kaneka Medical America LLC | NULL | Recruiting | N/A | 21 Years | All | 35 | N/A | United States |
| 64 | NCT01955187 (ClinicalTrials.gov) | January 2014 | 19/9/2013 | Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy | European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) | MEMBRANOUS NEPHROPATHY | Drug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDE | Hospital Universitario 12 de Octubre | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, Aachen | Completed | 18 Years | N/A | All | 86 | Phase 3 | Spain |
| 65 | NCT01791686 (ClinicalTrials.gov) | January 2013 | 29/1/2013 | Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease | A Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease | Dense Deposit Disease;Membranoproliferative Glomerulonephritis Type II;C3 Glomerulonephritis | Drug: CDX-1135 | Celldex Therapeutics | NULL | Terminated | 4 Years | N/A | Both | 1 | Phase 1 | United States |
| 66 | NCT01763580 (ClinicalTrials.gov) | July 16, 2012 | 6/12/2012 | A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) | MCNS;Minimal Change Nephrotic Syndrome (MCNS) | Drug: Tacrolimus;Drug: Prednisolone | Astellas Pharma Korea, Inc. | NULL | Completed | 16 Years | 78 Years | All | 144 | Phase 4 | Korea, Republic of |
| 67 | NCT01508468 (ClinicalTrials.gov) | January 17, 2012 | 9/12/2011 | Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy | Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab) | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | France |
| 68 | NCT01180036 (ClinicalTrials.gov) | November 2011 | 10/8/2010 | MEmbranous Nephropathy Trial Of Rituximab | A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Rituximab;Drug: Cyclosporine | Mayo Clinic | Columbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family Foundation | Completed | 18 Years | 80 Years | All | 130 | Phase 2/Phase 3 | United States;Canada |
| 69 | EUCTR2007-005410-39-ES (EUCTR) | 11/06/2008 | 08/04/2008 | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto. MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy | Trade Name: Advagraf 0,5mg INN or Proposed INN: tacrolimus Trade Name: Genoxal INN or Proposed INN: ciclofosfamida Trade Name: Dacortín 2,5mg INN or Proposed INN: prednisona Trade Name: Advagraf 1mg INN or Proposed INN: tacrolimus Trade Name: Advagraf 5mg INN or Proposed INN: tacrolimus Trade Name: Dacortín 5mg INN or Proposed INN: prednisona Trade Name: Dacortín 30mg INN or Proposed INN: prednisona | Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Spain | |||
| 70 | NCT00782561 (ClinicalTrials.gov) | April 2008 | 27/10/2008 | Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS) | A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: FG-3019 | FibroGen | NULL | Terminated | 12 Years | 64 Years | All | 2 | Phase 1 | United States |
| 71 | NCT00464321 (ClinicalTrials.gov) | May 2007 | 20/4/2007 | Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS | A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS) | Focal Segmental Glomerulosclerosis | Biological: GC1008 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 1 | United States;Germany;Italy;United Kingdom |
| 72 | NCT00983034 (ClinicalTrials.gov) | March 2006 | 21/9/2009 | The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy | Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy | Nephrotic Syndrome;Glomerulonephritis;Membranous Nephropathy | Drug: lansoprazole, amoxicillin, clarithromycin | Istanbul University | NULL | Completed | 18 Years | 70 Years | Both | 70 | N/A | Turkey |
| 73 | JPRN-C000000369 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome | membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome | CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks | Project team for treatment of refractory nephrotic syndrome | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 300 | Not selected | Japan | |
| 74 | JPRN-C000000368 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome | membranous nephropathy with primary steroid resistant nephrotic syndrome | mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years. | Project team for treatment of refractory nephrotic syndrome | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 100 | Not selected | Japan | |
| 75 | NCT00404833 (ClinicalTrials.gov) | January 2003 | 27/11/2006 | Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental | A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) | Glomerulonephritis, Membranous;Glomerulosclerosis, Focal | Drug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucil | Hospital Authority, Hong Kong | The University of Hong Kong | Completed | 18 Years | 65 Years | Both | 16 | Phase 3 | China |
| 76 | NCT00135967 (ClinicalTrials.gov) | May 2002 | 25/8/2005 | Mycophenolate Mofetil in Membranous Nephropathy | Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study | Glomerulonephritis, Membranous | Drug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9 | Radboud University | Hoffmann-La Roche | Completed | 18 Years | 75 Years | Both | 30 | Phase 2/Phase 3 | Netherlands |
| 77 | NCT00135954 (ClinicalTrials.gov) | July 1997 | 25/8/2005 | Treatment of Patients With Idiopathic Membranous Nephropathy | Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy | Glomerulonephritis, Membranous | Drug: Cyclophosphamide and steroids | Radboud University | NULL | Completed | 18 Years | 75 Years | Both | 29 | Phase 3 | Netherlands |
| 78 | EUCTR2016-003525-42-BE (EUCTR) | 30/10/2017 | A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) | biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 | Achillion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Australia;Netherlands | |||
| 79 | 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 | |||
| 80 | EUCTR2015-001039-18-Outside-EU/EEA (EUCTR) | 03/07/2015 | Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study | Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | Astellas Pharma Korea, Inc. | NULL | NA | Female: yes Male: yes | 152 | Korea, Republic of | ||||
| 81 | 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 | |||
| 82 | 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 |