67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 216 / 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 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 | EUCTR2018-004651-20-GB (EUCTR) | 13/02/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2018-004651-20-DE (EUCTR) | 20/01/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 850 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan | ||
| 3 | EUCTR2018-004651-20-CZ (EUCTR) | 12/12/2019 | 23/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan | ||
| 4 | EUCTR2018-004651-20-IT (EUCTR) | 20/11/2019 | 05/01/2021 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone Metile Other descriptive name: Bardoxolone methyl Product Name: Bardoxolone methyl 10 mg Product Code: [RTA 402] INN or Proposed INN: bardoxolone methyl Other descriptive name: bardoxolone methyl Product Name: Bardoxolone methyl 20 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone methyl Other descriptive name: Bardoxolone methyl Product Name: Bardoxolone methyl 15 mg Product Code: [RTA 402] INN or Proposed INN: Bardoxolone Methyl Other descriptive name: Bardoxolone methyl | REATA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2018-004651-20-ES (EUCTR) | 19/11/2019 | 04/09/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2018-004651-20-BE (EUCTR) | 14/10/2019 | 29/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease 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] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Japan;Italy | ||
| 7 | NCT03918447 (ClinicalTrials.gov) | May 29, 2019 | 12/4/2019 | A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON | A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney;ADPKD | Drug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsule | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 550 | Phase 3 | United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom |
| 8 | JPRN-UMIN000039943 | 2019/03/08 | 25/03/2020 | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease - A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE | Chronic Kidney DiseaseAlport SyndromeAutosomal Dominant Polycystic Kidney | Bardoxolone methyl | Reata Pharmaceuticals, Inc. | Kyowa Kirin Co., Ltd. | Recruiting | Not applicable | Not applicable | Male and Female | 480 | Phase 3 | Japan,North America,Australia,Europe |
| 9 | NCT03749447 (ClinicalTrials.gov) | March 8, 2019 | 19/11/2018 | An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease | Chronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 12 Years | N/A | All | 480 | Phase 3 | United States;Puerto Rico;Japan;Australia |
| 10 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |