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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alport Syndrome

In brief

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.

Key facts

Study ID

NCT03019185

Run by

Biogen

People needed

187

Starts

2017-03-02

Expected to finish

2020-10-30

Last updated by the study team

2025-06-11

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients 12 ≤ age ≤ 60 upon study consent;
• Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy;
• Screening eGFR ≥ 30 and ≤ 90 mL/min/1.73 m2. The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%;
• Albumin to creatinine ratio (ACR) ≤ 3500 mg/g at Screen B visit;
• If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), the medications must remain the same for at least 6 weeks prior to the Screen A visit and during Screening. The dosage of ACE inhibitor and/or ARB must also be stable for 2 weeks prior to the Screen A visit and remain the same through Day 1 (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to the Screen A visit;
• Adequate bone marrow reserve and organ function at the Screen A visit
• Able to swallow capsules;
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

You may not qualify if…

• Prior exposure to bardoxolone methyl;
• Ongoing chronic hemodialysis or peritoneal dialysis therapy;
• Renal transplant recipient;
• B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
• Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
• Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
• Serum albumin < 3 g/dL at Screen A visit;
• History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
• Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest;
• Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
• History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
• Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
• Untreated or uncontrolled active bacterial, fungal, or viral infection;
• Participation in other interventional clinical studies within 30 days prior to Day 1;
• Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
• Women who are pregnant or breastfeeding;
• Known hypersensitivity to any component of the study drug

Where it is running

• Arizona Kidney Disease and Hypertension Research Services, PLLC — Phoenix, Arizona, United States
• Scripps Clinic, Nephrology — La Jolla, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• General Clinical Research Center - Parnassus — San Francisco, California, United States
• University of California San Francisco - Children's Renal Center — San Francisco, California, United States
• Denver Nephrologists PC — Denver, Colorado, United States
• South Florida Research Institute — Lauderdale Lakes, Florida, United States
• Emory University School of Medicine and Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Boise Kidney & Hypertension Institute — Caldwell, Idaho, United States
• Boise Kidney & Hypertension Institute — Meridian, Idaho, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Biolab Research, LLC — Rockville, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota - Division of Pediatric Nephrology — Minneapolis, Minnesota, United States
• Children's Research Institute - The Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack Meridian School of Medicine — Hackensack, New Jersey, United States
• Nephrology Associates, PC — Flushing, New York, United States
• Columbia University Nephrology — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Brookview Hills Research Associates, PLLC — Winston-Salem, North Carolina, United States
• Akron Nephrology Associates — Akron, Ohio, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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