IRVING, Texas and ABBOTT PARK, Ill., June 16, 2011 /PRNewswire/
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
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