Patients with advanced chronic kidney disease (CKD) and type 2 diabetes who took bardoxolone, a first-in-class oral antioxidant inflammation modulator, continued to show improvements in their estimated glomerular filtration rates (eGFR) at 52 weeks, mirroring results at 24 weeks that were presented at least year’s American Society of Nephrology meeting in Denver.
Speaking at the 48th Congress of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) in Prague, David Warnock, MD, professor of medicine at the University of Alabama at Birmingham, told the congress that these latest results suggest that the drug may be useful for treating CKD, although larger confirmatory trials are still needed. The findings were published online by the New England Journal of Medicine on June 24.
The phase 2b, randomized, double-blind, placebo-controlled Bardoxolone Methyl Treatment: Renal Function in CKD/Type 2 Diabetes (BEAM) trial (NCT00811889) assigned 227 adults with type 2 diabetes and an eGFR of 20–45 mL/min/1.73 m2 equally to 1of 4 groups: bardoxolone at a dose of 25 mg, 75 mg, or 150 mg once daily, or to placebo. All patients received the standard of care of a renin-angiotensin-aldosterone system blocker unless they could not tolerate them. The primary endpoint was the change in eGFR from baseline with bardoxolone compared to placebo at 24 weeks, and the secondary endpoint of the change at 52 weeks was reported at the ERA-EDTA meeting.
Baseline variables for the four treatment groups were similar: a mean age of 67 years, a time from diabetes diagnosis of approximately 18 years, and a body mass index of 35.0–36.3 kg/m2. The mean eGFR was 32.4 ± 6.9 mL/min/1.73 m2. Blood glucose levels and blood pressure were generally well controlled.