218. アルポート症候群 [臨床試験数:16,薬物数:24(DrugBank:11),標的遺伝子数:5,標的パスウェイ数:27

Searched query = "Alport syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03749447March 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;Japan;Puerto Rico
2JPRN-UMIN0000324482018/05/0101/05/2018A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport SyndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport SyndromeDrug: 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, IncNULLComplete: follow-up continuing12years-old70years-oldMale and Female180Phase 2/3Japan,North America,Australia,Europe
3EUCTR2016-004395-22-GB28/03/201831/10/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA 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]
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Spain;Australia;Germany;United Kingdom
4EUCTR2016-004395-22-DE19/12/201725/09/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA 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]
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Spain;Australia;Germany;United Kingdom
5EUCTR2016-004395-22-FR04/12/201705/12/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0Level: PTClassification code 10001843Term: Alport's syndromeSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03019185March 2, 20176/1/2017A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINALA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport SyndromeAlport SyndromeDrug: Placebo Oral Capsule;Drug: Bardoxolone MethylReata Pharmaceuticals, Inc.NULLCompleted12 Years60 YearsAll187Phase 2/Phase 3United States;Australia;France;Germany;Japan;Puerto Rico;Spain;United Kingdom;Canada