67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 221 / 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
| 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 | NCT02055079 (ClinicalTrials.gov) | April 2014 | 31/1/2014 | Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease | Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP Study | Polycystic Kidney, Type 1 Autosomal Dominant Disease;Polycystic Kidney, Type 2 Autosomal Dominant Disease | Drug: Sirolimus;Drug: Placebo | Medical University of Vienna | NULL | Unknown status | 18 Years | N/A | All | 68 | Phase 3 | Austria |
| 2 | EUCTR2012-000550-60-AT (EUCTR) | 17/01/2014 | 27/11/2013 | Pulsed oral sirolimus in autosomal dominant polycystic kidney disease | Pulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP Study | Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy. MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Rapamune 1mg tablets Product Name: Rapamune 1mg tablets INN or Proposed INN: SIROLIMUS | Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 3 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 68 | Phase 3 | Austria | ||
| 3 | NCT01680250 (ClinicalTrials.gov) | September 2011 | 30/8/2012 | Sirolimus for Massive Polycystic Liver | An Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic Liver | Polycystic Kidney Diseases | Drug: Sirolimus | Seoul National University Hospital | Wyeth is now a wholly owned subsidiary of Pfizer | Recruiting | 18 Years | 65 Years | Both | 44 | Phase 2/Phase 3 | Korea, Republic of |
| 4 | NCT01223755 (ClinicalTrials.gov) | September 2010 | 12/10/2010 | Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency | EFFECTS OF SIROLIMUS ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND SEVERE RENAL INSUFFICIENCY | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Sirolimus;Drug: conventional therapy | Mario Negri Institute for Pharmacological Research | NULL | Terminated | 18 Years | 80 Years | Both | 41 | Phase 2/Phase 3 | Italy |
| 5 | NCT01632605 (ClinicalTrials.gov) | November 2009 | 13/5/2012 | The Vienna RAP Pilot Study | Rapamycin in Advanced Polycystic Kidney Disease Pilot Study | ADPKD | Drug: Sirolimus | Medical University of Vienna | NULL | Completed | 18 Years | N/A | Both | 8 | N/A | Austria |
| 6 | NCT00920309 (ClinicalTrials.gov) | June 2009 | 12/6/2009 | Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy | Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy | Autosomal Dominant Polycystic Kidney Disease | Drug: Rapamycin;Other: Standard of Care-Placebo | Yale University | NULL | Terminated | 18 Years | 70 Years | All | 21 | Phase 2/Phase 3 | United States |
| 7 | EUCTR2007-005047-21-IT (EUCTR) | 24/12/2007 | 02/07/2008 | Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II | Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease | Trade Name: RAPAMUNE*100CPR RIV 1MG INN or Proposed INN: Sirolimus Trade Name: RAPAMUNE*30CPR RIV 2MG INN or Proposed INN: Sirolimus | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 8 | EUCTR2007-006557-25-IT (EUCTR) | 20/12/2007 | 18/12/2007 | RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY | RAPAMYCIN FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE - RAPYD-STUDY | ADPKD type I MedDRA version: 9.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders | Trade Name: RAPAMUNE*100CPR RIV 1MG INN or Proposed INN: Sirolimus Product Name: Ramipril INN or Proposed INN: Ramipril | AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 9 | NCT00491517 (ClinicalTrials.gov) | March 2007 | 25/6/2007 | Sirolimus Treatment in Patients With Autosomal Dominant Polycystic Kidney Disease: Renal Efficacy and Safety | Sirolimus Treatment in Patients With ADPKD | Polycystic Kidney | Drug: Sirolimus;Drug: conventional therapy | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 80 Years | Both | 22 | Phase 2 | Italy |
| 10 | EUCTR2006-003427-37-IT (EUCTR) | 05/02/2007 | 27/12/2006 | Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND | Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND | Autosomal-Dominant Polycystic Kidney Disease ADPKD MedDRA version: 9.1;Level: LLT;Classification code 10010428;Term: Congenital cystic kidney disease | Trade Name: RAPAMUNE*30CPR RIV 1MG INN or Proposed INN: Sirolimus Trade Name: RAPAMUNE*30CPR RIV 2MG INN or Proposed INN: Sirolimus | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 11 | NCT00286156 (ClinicalTrials.gov) | October 2006 | 1/2/2006 | Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney Diseases | Drug: Rapamune | The Cleveland Clinic | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | 18 Years | 75 Years | All | 30 | Phase 1/Phase 2 | United States |
| 12 | NCT00346918 (ClinicalTrials.gov) | June 2006 | 22/6/2006 | Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study. | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Sirolimus;Other: Standard | University of Zurich | NULL | Completed | 18 Years | 40 Years | Both | 100 | Phase 3 | Switzerland |