At a glance
ClinicalIndex Comparison Record- ✓Age 12-60 years at study consent
- ✓Diagnosis of Alport syndrome confirmed by genetic testing (COL4A3, COL4A4, or COL4A5 mutation) or electron microscopy
- ✓eGFR 30-90 mL/min/1.73 m² with ≤25% difference between two screening values
- ✓Albumin-to-creatinine ratio ≤3500 mg/g at screening
- ✕Prior exposure to bardoxolone methyl
- ✕Currently on or anticipated need for chronic hemodialysis or peritoneal dialysis
- ✕Renal transplant recipient
- ✕BNP >200 pg/mL at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome
In Brief
A Phase 3 clinical trial evaluating Placebo Oral Capsule and Bardoxolone Methyl for Alport Syndrome. Completed, enrolled 187 participants across 63 sites in 8 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Capsule containing an inert placebo
Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.