Reata and Abbott Initiate Global Phase 3 Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
IRVING, Texas and ABBOTT PARK, Ill., June 16, 2011 /PRNewswire/ -- Reata Pharmaceuticals, Inc. and Abbott announced today the initiation of a pivotal Phase 3 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 multinational, 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.
More information on the trial is available at www.clinicaltrials.gov (clinical trial identifier: NCT01351675).
"We are pleased to announce that the Phase 3 BEACON trial is underway," said Pablo E. Pergola, M.D., Ph.D., Director of Renal Associates' Research Di