A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

March 2, 2017

Primary Completion Date

October 6, 2020

Study Completion Date

October 30, 2020

Conditions
Alport Syndrome
Interventions
DRUG

Placebo Oral Capsule

Capsule containing an inert placebo

DRUG

Bardoxolone Methyl

Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.

Trial Locations (63)

2145

Royal Brisbane and Women's Hospital, Herston

10032

Columbia University Nephrology, New York

11355

Nephrology Associates, PC, Flushing

15224

University of Pittsburgh School of Medicine - Division of Pediatric Nephrology, Pittsburgh

19104

Children's Hospital of Philadelphia (CHOP), Philadelphia

20852

Biolab Research, LLC, Rockville

27103

Brookview Hills Research Associates, PLLC, Winston-Salem

27701

Duke University Medical Center, Durham

29118

South Carolina Nephrology & Hypertension Center, Inc, Orangeburg

30120

Hospital Virgen de la Arrixaca, El Palmar

30322

Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta

33313

South Florida Research Institute, Lauderdale Lakes

35294

University of Alabama at Birmingham, Birmingham

37075

University of Medicine Gottingen, Göttingen

38700

CHU Grenoble- Grenoble France, La Tronche

44195

Cleveland Clinic, Cleveland

44302

Akron Nephrology Associates, Akron

44308

Akron Children's Hospital, Akron

45220

University of Cincinnati, Cincinnati

48109

University of Michigan, Ann Arbor

55454

University of Minnesota - Division of Pediatric Nephrology, Minneapolis

60201

NorthShore University Health System, Evanston

63110

Washington University School of Medicine, St Louis

64108

Children's Research Institute - The Children's Mercy Hospital, Kansas City

69003

CHU Lyon-Hopital Edouard Herriot, Lyon

69120

University Children's Hospital Heidelberg, Heidelberg

75015

Hopital Necker-Universite Paris Descartes, Paris

75235

Renal Disease Research Institute, Dallas

77099

Southwest Houston Research, Houston

78215

Clinical Advancement Center, San Antonio

80230

Denver Nephrologists PC, Denver

83605

Boise Kidney & Hypertension Institute, Caldwell

83642

Boise Kidney & Hypertension Institute, Meridian

84088

Advanced Clinical Research, West Jordan

84132

University of Utah Health, Salt Lake City

85308

Arizona Kidney Disease and Hypertension Research Services, PLLC, Phoenix

90022

Academic Medical Research Institute, Los Angeles

90095

David Geffen School of Medicine at UCLA, Los Angeles

92037

Scripps Clinic, Nephrology, La Jolla

94143

General Clinical Research Center - Parnassus, San Francisco

University of California San Francisco - Children's Renal Center, San Francisco

97239

Oregon Health & Science University, Portland

02111

Tufts Medical Center, Boston

07601

Hackensack Meridian School of Medicine, Hackensack

02903

The Warren Alpert Medical School of Brown University, Providence

VIC 3073

Melbourne Renal Research Group, Melbourne

NSW 2305

John Hunter Hospital, New Lambton Heights

NSW 2031

Sydney Children's Hospital, Sydney

NSW 2145

The Children's Hospital at Westmead, Westmead

Unknown

St Marianna University Hospital, Kawasaki

Kobe University Hospital, Kobe

Japanese Red Cross Nagoya Daini Hospital, Nagoya

JCHO Cyukyo Hospital, Nagoya

Kitano Hospital, Osaka

Saga University Hospital, Saga

Saitama Children's Medical Center, Saitama

JCHO Sendai Hospital, Sendai

Juntendo University Hospital, Tokyo

Tokyo Metropolitan Children's Medical Center, Tokyo

00935

Puerto Rico Clinical & Translational Research Center, Rio Piedras

119-08035

Servicio de Nefrologia pediatrica, Barcelona

340-08025

Fundacio Puigvert, Barcelona

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY