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 | 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 | |||
| 2 | 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 |
| 3 | NCT01185197 (ClinicalTrials.gov) | September 2010 | 13/8/2010 | Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study | Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome | Nephrosis, Lipoid | Drug: Myfortic plus low-dose steroid;Drug: Prednisolone | The University of Hong Kong | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 4 | China |
| 4 | EUCTR2009-016003-26-GB (EUCTR) | 06/05/2010 | 17/03/2010 | RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic | RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic | Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders | Trade Name: Myfortic Product Name: Myfortic 360mg Tablets INN or Proposed INN: mycophenolic acid Other descriptive name: mycophenolate sodium Trade Name: Myfortic Product Name: Myfortic 180mg Tablets INN or Proposed INN: mycophenolic sodium Other descriptive name: mycophenolate sodium Product Name: Prednisolone INN or Proposed INN: prednisolone | UHB NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United Kingdom | ||
| 5 | 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 | |
| 6 | JPRN-UMIN000000621 | 2007/03/01 | 28/02/2007 | Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission | Minimal change nephrotic syndrome | Prednisolone (+), combination therapy (-) Prednisolone (+), combination therapy (+) | Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 |
| 10 | JPRN-C000000379 | 2001/04/01 | 01/04/2006 | Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) | Steroid-sensitive nephrotic syndrome | prednisolone mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 1years-old | 10years-old | Male and Female | 50 | Not selected | Japan | |
| 11 | 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 |