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 | 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 | |
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | ChiCTR2000032422 | 2020-09-01 | 2020-04-27 | The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study | The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study | Idiopathic membranous nephropathy | experimental group:Tacrolimus;control group:conservative treatment; | Shenzhen Second People's Hospital | NULL | Pending | Both | experimental group:24;control group:24; | Phase 4 | Chiina | ||
| 6 | 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 |
| 7 | ChiCTR2000031003 | 2020-03-25 | 2020-03-20 | Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen | Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen | Idiopathic focal segmental glomerulosclerosis | Tacrolimus group:Low dose of tacrolimus combined with hormone;hormone group:Use hormones; | Southwest Hospital, the First Affiliated Hospital of Army Medical University | NULL | Recruiting | Both | Tacrolimus group:19;hormone group:19; | Phase 4 | China | ||
| 8 | ChiCTR1900022943 | 2019-05-03 | 2019-05-04 | Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome | Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome | Nephrotic Syndrome | Case Series:Tacrolimus; | Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | Both | Case Series:100; | Phase 4 | China | ||
| 9 | NCT03864250 (ClinicalTrials.gov) | November 26, 2018 | 4/3/2019 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial | Tacrolimus;Idiopathic Membranous Nephropathy;Clinical Trial | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 124 | N/A | China |
| 10 | NCT03549663 (ClinicalTrials.gov) | July 4, 2018 | 10/5/2018 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 108 | N/A | China |
| 11 | 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 | |
| 12 | ChiCTR1800014719 | 2018-02-01 | 2018-01-31 | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | idiopathic focal segmental glomerulosclerosis | tacrolimus group:nothing;prednisone group:nothing; | the First Affiliated Hospital of Third Military Medical University | NULL | Recruiting | Both | tacrolimus group:24;prednisone group:17; | China | |||
| 13 | 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 |
| 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 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | ChiCTR-TRC-11001454 | 2011-08-01 | 2011-08-08 | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | minimal change disease in adults;ICD10:N04.001 | Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Completed | Both | Group A:60;Group B:60; | China | |||
| 20 | NCT01162005 (ClinicalTrials.gov) | July 2010 | 12/7/2010 | Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children | Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children | Nephrotic Syndrome | Drug: Tacrolimus | Seoul National University Hospital | Chong Kun Dang Pharmaceutical | Completed | N/A | 18 Years | All | 77 | Phase 4 | Korea, Republic of |
| 21 | NCT01161459 (ClinicalTrials.gov) | June 2010 | 12/7/2010 | Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid | Research Institute of Nephrology, Jinling Hospital | Idiopathic Membranous Nephropathy | Drug: Tripterygium wilfordii;Drug: FK506 | Zhi-Hong Liu, M.D. | NULL | Completed | 18 Years | 65 Years | Both | 100 | N/A | China |
| 22 | 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 | |||
| 23 | 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 | |
| 24 | NCT00302536 (ClinicalTrials.gov) | March 2006 | 13/3/2006 | Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis | Tacrolimus Treatment of Patients With Idiopathic Focal Segmental | Focal Glomerulosclerosis | Drug: Tacrolimus | Nanjing University School of Medicine | NULL | Withdrawn | 15 Years | 50 Years | Both | 0 | N/A | China |
| 25 | NCT00302523 (ClinicalTrials.gov) | March 2006 | 13/3/2006 | Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy | Tacrolimus Treatment of Patients With Idiopathic | Idiopathic Membranous Nephropathy | Drug: Tacrolimus | Nanjing University School of Medicine | NULL | Completed | 18 Years | 60 Years | Both | 16 | N/A | China |
| 26 | NCT00362531 (ClinicalTrials.gov) | November 2004 | 9/8/2006 | Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Idiopathic Membranous Nephropathy;Nephrotic Syndrome | Drug: tacrolimus combined with prednisone | Peking University | NULL | Completed | 18 Years | 70 Years | Both | Phase 2/Phase 3 | NULL | |
| 27 | ChiCTR-TRC-09000539 | 2004-03-01 | 2009-09-30 | Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy | Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy | Nephrotic Disease | S:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months; | Second Hospital of Jilin University | NULL | Completed | 16 | 69 | Both | S:10;L:10; | China | |
| 28 | 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 |