Reata and Abbott initiate global phase III study of Bardoxolone Methyl
Reata Pharmaceuticals and Abbott have initiated a pivotal phase III clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with chronic kidney disease (eGFR of 15-29 mL/min/1.73 m2) and Type 2 diabetes.
The trial, known as BEACON (Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes: the Occurrence of renal eveNts), is the first multi-national, double-blind, placebo-controlled study designed to assess the impact of bardoxolone methyl on time to important clinical outcomes. Approximately 1,600 patients at 300 sites worldwide - including in Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Mexico, Spain, Sweden, United Kingdom and United States - will be enrolled in the trial and randomized 1:1 to receive 20 mg of a reformulated version of bardoxolone methyl or placebo once daily. Results are expected in 2013.
The primary efficacy endpoint will be a time-to-first-event composite consisting of progression to end-stage renal disease (ESRD), defined as the need for chronic dialysis or renal transplant, and cardiovascular death. Secondary endpoints will include change in estimated glomerular filtration rate (eGFR) and a time-to-first-event composite consisting of hospitalization for congestive heart failure (CHF), non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death.