Last updated on November 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

Caitlin Carter, MD

Scripps Clinic, Nephrology
La Jolla, CA United States

Mohamed El-Shahawy, MD

Academic Medical Research Institute
Los Angeles, CA United States

Anjay Rastogi, MD

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

Geoffrey Block, MD

Denver Nephrologists PC
Denver, CO United States

Edouard Martin, MD

South Florida Research Institute
Lauderdale Lakes, FL United States

Larry Greenbaum, MD

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

Arnold Silva, MD

Boise Kidney & Hypertension Institute
Caldwell, ID United States

Arnold Silva, MD

Boise Kidney & Hypertension Institute
Meridian, ID United States

Stuart Sprague, MD

NorthShore University Health System
Evanston, IL United States

Mario Belledonne, MD

Biolab Research, LLC
Rockville, MD United States

Lesley Inker, MD

Tufts Medical Center
Boston, MA United States

Larysa Wickman, MD

University of Michigan
Ann Arbor, MI United States

Michelle Rheault, MD

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

George Jarad, MD

Washington University School of Medicine
Saint Louis, MO United States

Bruce Spinowitz, MD

Nephrology Associates, PC
Flushing, NY United States

Gerald Appel, MD

Columbia University Nephrology
New York, NY United States

Kotagal Kant, MD

University of Cincinnati
Cincinnati, OH United States

James Simon, MD

Cleveland Clinic
Cleveland, OH United States

Moustafa Moustafa, MD

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

Bernard Fischbach, MD

Renal Disease Research Institute
Dallas, TX United States

Marializa Bernardo, MD

Southwest Houston Research
Houston, TX United States

Pablo Pergola, MD

Clinical Advancement Center
San Antonio, TX United States

Martin Gregory, MD

University of Utah Health
Salt Lake City, UT United States

Peter Santos, MD

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

Farzana Perwad, MD

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

Ferzana Perwad, MD

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

Bradley Warady, MD

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

Rasheed Gbadegesin, MD

Duke University Medical Center
Durham, NC United States

Gregory Greenwood, MD

Brookview Hills Research Associates, PLLC
Winston-Salem, NC United States

Amira Al-Uzri, MD

Oregon Health & Science University
Portland, OR United States

Kevin Meyers, MD

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

Christina Nguyen, MD

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

Mohammed Faizan, MD

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

Judith Kirstein, MD

Advanced Clinical Research
West Jordan, UT United States

Hanh Nguyen

South Western Sydney Local Health Network
Liverpool, Australia

Andrew Mallett, MD

Royal Brisbane and Women's Hospital
Herston, Australia

David Packham, MD

Melbourne Renal Research Group
Melbourne, Australia

Alastair Gillies, MD

John Hunter Hospital
New Lambton Heights, Australia

Hugh McCarthy, MD

Sydney Children's Hospital
Sydney, Australia

Anne Durkan, MD

The Children's Hospital at Westmead
Westmead, Australia

Philippe Zaoui, MD

CHU Grenoble- Grenoble France
La Tronche, France

Sandrine Lemoine, MD

CHU Lyon-Hopital Edouard Herriot
Lyon, France

Bertrand Knebelmann, MD

Hopital Necker-Universite Paris Descartes
Paris, France

Burkhard Toenshoff, MD

University Children's Hospital Heidelberg
Heidelberg, Germany

Isao Aoyama, MD

JCHO Cyukyo Hospital
Nagoya, Japan

Yasufumi Ohtsuka, MD

Saga University Hospital
Saga, Japan

Toshinobu Sato, MD

JCHO Sendai Hospital
Sendai, Japan

Yusuke Suzuki, MD

Juntendo University Hospital
Tokyo, Japan

Rafael Burgos-Calderon, MD

Puerto Rico Clinical & Translational Research Center
Rio Piedras, Puerto Rico

Gema Ariceta, MD

Servicio de Nefrologia pediatrica
Barcelona, Spain

Roser Torra, MD

Fundacio Puigvert
Barcelona, Spain

Victor Martinez, MD

Hospital Virgen de la Arrixaca
El Palmar, Spain

Hanh Nguyen

University of Glasgow
Glasgow, United Kingdom

Daniel Gale, MD

Royal Free Hospital
London, United Kingdom

Kenneth Lieberman

Hackensack Meridian School of Medicine
Hackensack, NJ United States

Rupesh Raina

Akron Children's Hospital
Akron, OH United States

Yugo Shibagaki

St Marianna University Hospital
Kawasaki, Japan

Yoshimitsu Gotoh

Japanese Red Cross Nagoya Daini Hospital
Nagoya, Japan

Syuichiro Fujinaga

Saitama Children's Medical Center
Saitama, Japan

Riku Hamada

Tokyo Metropolitan Children`s Medical Center
Tokyo, Japan

Hanh Nguyen

Edinburgh University
Edinburgh, United Kingdom

Kandai Nozu, MD

Kobe University Hospital
Kobe, Japan

Tatsuo Tsukamoto, MD

Kitano Hospital
Osaka, Japan

Rupesh Raina

Akron Nephrology Associates
Akron, OH United States

Oliver Gross, MD

University of Medicine Gottingen
Göttingen, Germany

Recruitment Status: Closed


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