222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| 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 | 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 | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Czech Republic;Argentina;Singapore;Germany;Netherlands;China | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | EUCTR2018-003437-15-FR (EUCTR) | 03/04/2019 | 27/02/2019 | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS | Minimal Change Nephrotic Syndrome (MCNS) MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 6 | 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 | |||
| 7 | EUCTR2011-006115-59-IT (EUCTR) | 11/06/2012 | 08/06/2012 | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011 | MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: MABTHERA*EV 1FL 50ML 500MG Trade Name: URBASON*IM EV 1F 250MG+1F 5ML Trade Name: MEDROL*10CPR DIV 4MG Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 8 | EUCTR2008-006750-17-IT (EUCTR) | 14/04/2009 | 27/01/2009 | A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO | A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO | Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS. MedDRA version: 9.1;Level: LLT;Classification code 10029171 MedDRA version: 9.1;Classification code 10058326 MedDRA version: 9.1;Classification code 10016832 | Trade Name: MABTHERA INN or Proposed INN: Rituximab Trade Name: MABTHERA INN or Proposed INN: Rituximab | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy |