218. アルポート症候群 Alport syndrome Clinical trials / Disease details
臨床試験数 : 30 / 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46
| 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 | 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;Australia;France;Japan;Puerto Rico;Spain |
| 2 | JPRN-UMIN000032448 | 2018/05/01 | 01/05/2018 | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome | Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status. Dosing period is up to 2 years. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 2 years. | Reata Pharmaceuticals, Inc | NULL | Complete: follow-up complete | 12years-old | 70years-old | Male and Female | 180 | Phase 2/3 | Japan,North America,Australia,Europe |
| 3 | EUCTR2016-004395-22-GB (EUCTR) | 28/03/2018 | 31/10/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone Methyl 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 | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Australia;Germany;United Kingdom | ||
| 4 | EUCTR2016-004395-22-ES (EUCTR) | 24/01/2018 | 07/11/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Germany;United Kingdom | ||
| 5 | EUCTR2016-004395-22-DE (EUCTR) | 19/12/2017 | 25/09/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Germany;United Kingdom | ||
| 6 | EUCTR2016-004395-22-FR (EUCTR) | 04/12/2017 | 05/12/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Germany;United Kingdom | ||
| 7 | NCT03019185 (ClinicalTrials.gov) | March 2, 2017 | 6/1/2017 | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome | Alport Syndrome | Drug: Placebo Oral Capsule;Drug: Bardoxolone Methyl | Reata Pharmaceuticals, Inc. | NULL | Completed | 12 Years | 60 Years | All | 187 | Phase 2/Phase 3 | United States;Australia;France;Germany;Japan;Puerto Rico;Spain;United Kingdom;Canada |