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.
Part 2 of MOXIe was a Phase 2 international, multicenter, double-blind, randomized, and placebo-controlled study in patients with Friedreich’s ataxia, a rare, progressive, and debilitating genetic disorder with no approved treatments.
The effects of dihydro‐CDDO‐trifluoroethyl amide (dh404), a rodent‐tolerable bardoxolone methyl analog, on the tubulointerstitium, were tested in an Institute of Cancer Research‐derived glomerulonephritis (ICGN) mouse model of kidney disease. The effect of dh404 on mitochondrial function, was assessed using human proximal tubular cells in vitro.
Post-hoc analyses to characterize the relationship between the urine albumin-to-creatinine ratio and estimated glomerular filtration rate in response to bardoxolone methyl treatment in BEACON, a Phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial of bardoxolone methyl in 2,185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease.