ARTICLE | Clinical News

AKB-6548: Phase II data

April 9, 2012 7:00 AM UTC

A double-blind, placebo-controlled, U.S. Phase II trial in 93 patients with stage III or IV CKD showed that once-daily oral AKB-6548 met the primary endpoint of a dose-dependent increase in hemoglobin from baseline to day 42. Specifically, once-daily doses of 240-630 mg AKB-6548 increased hemoglobin by 0.7-1.4 g/dL from baseline (p<0.0001 for the dose-dependent trend). In patients receiving placebo, hemoglobin was reduced by an average of 0.1 g/dL from baseline to day 42. Akebia said the trial was not powered to compare AKB-6548 to placebo. ...