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

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004651-20-GB
(EUCTR)
13/02/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom
2EUCTR2018-004651-20-DE
(EUCTR)
20/01/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3France;United States;Czechia;Czech Republic;Belgium;Spain;Australia;Germany;United Kingdom;Italy;Japan
3EUCTR2018-004651-20-CZ
(EUCTR)
12/12/201923/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan
4EUCTR2018-004651-20-IT
(EUCTR)
20/11/201905/01/2021A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy
5EUCTR2018-004651-20-ES
(EUCTR)
19/11/201904/09/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-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): noFrance;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom
6EUCTR2018-004651-20-BE
(EUCTR)
14/10/201929/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Japan;Italy
7EUCTR2018-004651-20-FR
(EUCTR)
11/09/201908/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czech Republic;Belgium;United States;Denmark;Italy;United Kingdom;France;Australia;Germany;Spain
8NCT03918447
(ClinicalTrials.gov)
May 29, 201912/4/2019A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCONA Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsuleReata Pharmaceuticals, Inc.NULLRecruiting12 Years70 YearsAll850Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom
9NCT03749447
(ClinicalTrials.gov)
March 8, 201919/11/2018An 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 DiseaseChronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methylReata Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll480Phase 3United States;Australia;France;Japan;Puerto Rico;Spain
10JPRN-UMIN000039943
2019/03/0825/03/2020An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney DiseaseAn 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 KidneyBardoxolone methylReata Pharmaceuticals, Inc.Kyowa Kirin Co., Ltd.RecruitingNot applicableNot applicableMale and Female480Phase 3Japan,North America,Australia,Europe
11NCT03366337
(ClinicalTrials.gov)
December 26, 20174/12/2017A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXA Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney DiseasesIgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States