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 | 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 | ||
| 2 | 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 |
| 3 | 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 | ||
| 4 | EUCTR2018-004611-50-GB (EUCTR) | 14/06/2019 | 11/04/2019 | The Use of Rituximab IN treatment of immune-mediated Glomerulonephritis (TURING) | A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING) - TURING | Minimal Change Disease (MCD) and Focal segmental glomerulosclerosis (FSGS) | Product Name: Rituximab INN or Proposed INN: Rituximab | Cambridge University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 5 | EUCTR2017-001821-42-GB (EUCTR) | 02/08/2018 | 12/09/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | 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 |
| 7 | EUCTR2017-001821-42-IT (EUCTR) | 07/03/2018 | 14/11/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2017-001821-42-NL (EUCTR) | 13/02/2018 | 16/10/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 9 | EUCTR2017-001821-42-BE (EUCTR) | 15/01/2018 | 06/10/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2017-001821-42-DK (EUCTR) | 19/12/2017 | 25/10/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 11 | EUCTR2017-001821-42-ES (EUCTR) | 04/12/2017 | 24/10/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2017-001821-42-IE (EUCTR) | 01/12/2017 | 09/01/2018 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2017-001821-42-DE (EUCTR) | 22/11/2017 | 09/10/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy. | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 14 | EUCTR2017-001821-42-FR (EUCTR) | 06/11/2017 | 09/11/2017 | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy | C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | NCT00801463 (ClinicalTrials.gov) | January 2009 | 2/12/2008 | Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis | Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis | Proteinuria;Focal Segmental Glomerulosclerosis | Drug: tripterygium wilfordii (TW) | Nanjing University School of Medicine | NULL | Completed | 18 Years | 60 Years | Both | 67 | N/A | China |
| 16 | NCT00479622 (ClinicalTrials.gov) | August 2007 | 25/5/2007 | Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: TRU-015 | Wyeth is now a wholly owned subsidiary of Pfizer | Emergent Product Development Seattle LLC | Terminated | 18 Years | 70 Years | Both | 20 | Phase 1 | United States |
| 17 | NCT00518219 (ClinicalTrials.gov) | July 2007 | 16/8/2007 | To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN) | To Compare the Efficacy and Safety of TW vs Valsartan in the MN | Membranous Nephropathy | Drug: TW | Nanjing University School of Medicine | NULL | Completed | 18 Years | 65 Years | Both | 68 | Phase 4 | China |
| 18 | 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 | |
| 19 | 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 |