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 | NCT05532111 (ClinicalTrials.gov) | September 1, 2022 | 1/9/2022 | Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial | Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial | Efficacy and Safety | Drug: Rituximab combined with tacrolimus induction + rituximab maintenance;Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance;Drug: Glucocorticoid combined with cyclophosphamide induction + maintenance | RenJi Hospital | NULL | Not yet recruiting | 18 Years | 75 Years | All | 60 | N/A | NULL |
| 2 | ChiCTR2200059658 | 2022-05-01 | 2022-05-05 | Establishment and validation of the prediction model of membranous nephropathy | Establishment and validation of the prediction model of membranous nephropathy | membranous nephropathy | Cyclophosphamide based initial treatment:Cyclophosphamide based treatment;Cyclosporine based initial treatment:CNIs based treatment; | People’s Hospital of Guangxi Zhuang Autonomous Region | NULL | Recruiting | 14 | 80 | Both | Cyclophosphamide based initial treatment:400;Cyclosporine based initial treatment:400; | China | |
| 3 | ChiCTR2200057381 | 2022-03-01 | 2022-03-10 | Efficacy and safety of low-dose rituximab in the treatment of membranous nephropathy | Efficacy and safety of low-dose rituximab in the treatment of membranous nephropathy | membranous nephropathy | rituximab group:rituximab;control:hormone combined with cyclophosphamide; | Peking University Third Hospital | NULL | Pending | 18 | 80 | Both | rituximab group:68;control:135; | N/A | China |
| 4 | ChiCTR2100048518 | 2021-10-31 | 2021-07-09 | A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy | A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy | idiopathic membranous nephropathy | low-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No; | The Second Affiliated Hospital of Xi'an Jiaotong University | NULL | Pending | 18 | 70 | Both | low-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100; | China | |
| 5 | ChiCTR2100049205 | 2021-08-01 | 2021-07-25 | A prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phase | A prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phase | Membranous nephropathy | Group B:Cyclophosphamide combined with glucocorticoids;Group C:Low-dose Cyclophosphamide, glucocorticoid combined with rituximab;Group A:Rituximab; | Shanghai Dongfang Hospital | NULL | Recruiting | 18 | 75 | Both | Group B:30;Group C:30;Group A:30; | China | |
| 6 | NCT04745728 (ClinicalTrials.gov) | April 14, 2021 | 4/2/2021 | Different Immunosuppressive Treatment in iMN | Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: Cyclophosphamide;Drug: Rituximab | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 200 | Phase 3 | China |
| 7 | ChiCTR2000033766 | 2020-07-01 | 2020-06-11 | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Membranous nephropathy | 1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus; | The First Affiliated Hospital of Bengbu Medical College | NULL | Pending | 17 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 8 | ChiCTR1800019833 | 2019-01-01 | 2018-12-02 | Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone | Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone | Idiopathic Membranous Nephropathy | PLA2R???:Cyclophosphamide combined with hormone therapy ;PLA2R positive Group:Cyclophosphamide combined with hormone therapy; | Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical University | NULL | Pending | 18 | 85 | Male | PLA2R???:30;PLA2R positive Group:30; | China | |
| 9 | ChiCTR1800016140 | 2018-07-01 | 2018-05-14 | Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open study | A randomized controlled trial for the treatment of primary membranous nephropathy | primary membranous nephropathy | Tacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks; | Sichuan Provincial People's Hospital | NULL | Pending | 18 | 65 | Both | Tacrolimus group:45;Cyclophosphamide group:45; | China | |
| 10 | NCT05679336 (ClinicalTrials.gov) | May 1, 2018 | 28/11/2022 | Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy | Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy | Membranous Nephropathy - PLA2R Induced | Drug: Rituximab, Cyclophosphamide, and Corticosteroids | St. Petersburg State Pavlov Medical University | NULL | Recruiting | 18 Years | 75 Years | All | 40 | N/A | Russian Federation |
| 11 | NCT03466801 (ClinicalTrials.gov) | March 20, 2018 | 13/1/2018 | The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I. | The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: MP and CTX | Wenhu Liu | NULL | Terminated | 18 Years | 80 Years | All | 6 | N/A | China |
| 12 | ChiCTR-IPR-17011702 | 2017-07-01 | 2017-06-19 | Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid | Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid | membranous nephropathy | mizoribine group:treated with mizoribine and steroid;cyclophosphamide group:treated with cyclophosphamide and steroid; | Tianjin First Central Hospital | NULL | Pending | 18 | 65 | Both | mizoribine group:50;cyclophosphamide group:50; | China | |
| 13 | ChiCTR-IPR-16008527 | 2016-06-01 | 2016-05-24 | Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical study | Rituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study | Membranous nephropathy | CsA group:oral CsA and glucosteroid;RTX group:intravenous RTX;CTX:Intravenous cyclophosphamide and glucosteroid; | Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicine | NULL | Completed | 18 | 70 | Both | CsA group:60;RTX group:60;CTX:60; | Phase 4 | China |
| 14 | ChiCTR-IPR-16008344 | 2016-04-19 | 2016-04-22 | A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathy | A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy | idiopathic membranous nephropathy | A:cyclophosphamide ;B:tacrolimus; | Baoji Central Hospital | NULL | Recruiting | Both | A:30;B:30; | China | |||
| 15 | 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 | |||
| 16 | ChiCTR-IPR-14005366 | 2014-09-01 | 2014-01-10 | A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy | A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy | Atypical membranous nephropathy | Low-dose hormone plus cyclophosphamide (CTX) grou:hormone, cyclophosphamide, three months;hormone+CsA:hormone+CsA, three months; | Department of Nephrology, China-Japan Friendship Hospital | NULL | Recruiting | 18 | 70 | Both | Low-dose hormone plus cyclophosphamide (CTX) grou:20;hormone+CsA:20; | NULL | |
| 17 | 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 |
| 18 | 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 | ||||
| 19 | NCT03018535 (ClinicalTrials.gov) | January 2012 | 9/1/2017 | Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: Rituximab;Drug: Methylprednisolone;Drug: Cyclophosphamide | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | University of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina Gaslini | Active, not recruiting | 18 Years | N/A | All | 76 | Phase 3 | Italy |
| 20 | NCT01451489 (ClinicalTrials.gov) | October 13, 2011 | 5/8/2011 | The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis | A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis | FSGS | Drug: FK506;Drug: Cyclophosphamide | Nanjing University School of Medicine | NULL | Terminated | 14 Years | 65 Years | All | 70 | N/A | China |
| 21 | 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 | |||
| 22 | ChiCTR-TRC-10001024 | 2008-01-01 | 2010-09-14 | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | primary focal segmental glomerulosclerosis | group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ; | Shanghai Jiaotong University Affiliated Ruijin Hospital | NULL | Completed | 18 | 75 | Both | group A:30;group B:30; | China | |
| 23 | NCT00007475 (ClinicalTrials.gov) | December 2000 | 22/12/2000 | Permeability Factor in Focal Segmental Glomerulosclerosis | Permeability Factor in Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Procedure: Plasma exchange;Drug: Cyclophosphamide | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | N/A | All | 15 | Phase 1/Phase 2 | United States |
| 24 | 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 |