Last updated on February 2018

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


Brief description of study

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Detailed Study Description

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients in the Phase 3 cohort will be randomized 1:1 to either bardoxolone methyl or placebo and randomization will be stratified by baseline albumin to creatinine ratio (ACR). Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they received at Week 48 and will continue study drug treatment through Week 100. Patients will also be scheduled to be assessed at an in person follow up visit at Week 104, four weeks after the end of treatment.

Clinical Study Identifier: NCT03019185

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Dana Rizk, MD

University of Alabama at Birmingham
Birmingham, AL United States
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Caitlin Carter, MD

Scripps Clinic, Nephrology
La Jolla, CA United States
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Mohamed El-Shahawy, MD

Academic Medical Research Institute
Los Angeles, CA United States
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Anjay Rastogi, MD

David Geffen School of Medicine at UCLA
Los Angeles, CA United States
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Geoffrey Block, MD

Denver Nephrologists PC
Denver, CO United States
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Edouard Martin, MD

South Florida Research Institute
Lauderdale Lakes, FL United States
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Larry Greenbaum, MD

Emory University School of Medicine and Children's Healthcare of Atlanta
Atlanta, GA United States
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Arnold Silva, MD

Boise Kidney & Hypertension Institute
Caldwell, ID United States
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Arnold Silva, MD

Boise Kidney & Hypertension Institute
Meridian, ID United States
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Stuart Sprague, MD

NorthShore University Health System
Evanston, IL United States
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Mario Belledonne, MD

Biolab Research, LLC
Rockville, MD United States
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Lesley Inker, MD

Tufts Medical Center
Boston, MA United States
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Larysa Wickman, MD

University of Michigan
Ann Arbor, MI United States
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Michelle Rheault, MD

University of Minnesota - Division of Pediatric Nephrology
Minneapolis, MN United States
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George Jarad, MD

Washington University School of Medicine
Saint Louis, MO United States
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Bruce Spinowitz, MD

Nephrology Associates, PC
Flushing, NY United States
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Gerald Appel, MD

Columbia University Nephrology
New York, NY United States
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Kotagal Kant, MD

University of Cincinnati
Cincinnati, OH United States
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James Simon, MD

Cleveland Clinic
Cleveland, OH United States
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Moustafa Moustafa, MD

South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, SC United States
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Bernard Fischbach, MD

Renal Disease Research Institute
Dallas, TX United States
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Marializa Bernardo, MD

Southwest Houston Research
Houston, TX United States
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Pablo Pergola, MD

Clinical Advancement Center
San Antonio, TX United States
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Martin Gregory, MD

University of Utah Health
Salt Lake City, UT United States
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Peter Santos, MD

Arizona Kidney Disease and Hypertension Research Services, PLLC
Phoenix, AZ United States
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Farzana Perwad, MD

General Clinical Research Center - Parnassus
San Francisco, CA United States
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Ferzana Perwad, MD

University of California San Francisco - Children's Renal Center
San Francisco, CA United States
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Bradley Warady, MD

Children's Research Institute - The Children's Mercy Hospital
Kansas City, MO United States
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Rasheed Gbadegesin, MD

Duke University Medical Center
Durham, NC United States
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Gregory Greenwood, MD

Brookview Hills Research Associates, PLLC
Winston-Salem, NC United States
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Amira Al-Uzri, MD

Oregon Health & Science University
Portland, OR United States
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Kevin Meyers, MD

Children's Hospital of Philadelphia (CHOP)
Philadelphia, PA United States
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Christina Nguyen, MD

University of Pittsburgh School of Medicine - Division of Pediatric Nephrology
Pittsburgh, PA United States
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Mohammed Faizan, MD

The Warren Alpert Medical School of Brown University
Providence, RI United States
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Judith Kirstein, MD

Advanced Clinical Research
West Jordan, UT United States
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Michael Suranyi, MD

South Western Sydney Local Health Network
Liverpool, Australia
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Andrew Mallett, MD

Royal Brisbane and Women's Hospital
Herston, Australia
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David Packham, MD

Melbourne Renal Research Group
Melbourne, Australia
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Alastair Gillies, MD

John Hunter Hospital
New Lambton Heights, Australia
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Hugh McCarthy, MD

Sydney Children's Hospital
Sydney, Australia
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Anne Durkan, MD

The Children's Hospital at Westmead
Westmead, Australia
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Christoph Licht, MD

The Hospital for Sick Children
Toronto, ON Canada
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York Pei, MD

Toronto General Hospital, University Health Network
Toronto, ON Canada
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Philippe Zaoui, MD

CHU Grenoble- Grenoble France
La Tronche, France
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Sandrine Lemoine, MD

CHU Lyon-Hopital Edouard Herriot
Lyon, France
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Bertrand Knebelmann, MD

Hopital Necker-Universite Paris Descartes
Paris, France
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Oliver Gross, MD

University of Medicine Gottingen
Göttingen, Germany
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Burkhard Toenshoff, MD

University Children's Hospital Heidelberg
Heidelberg, Germany
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Isao Aoyama, MD

JCHO Cyukyo Hospital
Nagoya, Japan
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Yasufumi Otsuka, MD

Saga University Hospital
Saga, Japan
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Toshinobu Sato, MD

JCHO Sendai Hospital
Sendai, Japan
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Yusuke Suzuki, MD

Juntendo University Hospital
Tokyo, Japan
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Rafael Burgos-Calderon, MD

Puerto Rico Clinical & Translational Research Center
Rio Piedras, Puerto Rico
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Gema Ariceta, MD

Servicio de Nefrologia pediatrica
Barcelona, Spain
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Roser Torra, MD

Fundacio Puigvert
Barcelona, Spain
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Victor Martinez, MD

Hospital Virgen de la Arrixaca
El Palmar, Spain
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Alan Jardine, MD

University of Glasgow
Glasgow, United Kingdom
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Daniel Gale, MD

Royal Free Hospital
London, United Kingdom
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