The Phase 3 portion of CARDINAL is an international, multi-center, double-blind, placebo-controlled, randomized trial that enrolled 157 patients with chronic kidney disease caused by Alport syndrome. The primary endpoint for the study was the change in estimated glomerular filtration rate (eGFR) after 48 weeks of treatment. The key secondary endpoint for the study was the change in the off-treatment eGFR after 48 weeks of treatment and four weeks of drug withdrawal.
Disclaimer Bardoxolone methyl is an investigational drug. Safety and efficacy have not been established by any regulatory agency.