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

Inclusion Criteria: * 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; Exclusion Criteria: * Prior exposure to bardoxolone methyl; * Ongoing chronic hemodialysis or peritoneal dialysis therapy; * Renal transplant recipient; * B-type natriuretic peptide (BNP) level…