ARTICLE | Clinical News

Akebia's vadadustat meets in Phase II dialysis-dependent CKD

January 26, 2018 8:17 PM UTC

Akebia Therapeutics Inc. (NASDAQ:AKBA) reported top-line data from a double-blind, Japanese Phase II study in 60 patients with anemia associated with dialysis-dependent chronic kidney disease (CKD) showing that 150, 300 and 600 mg doses of oral vadadustat each met the primary endpoint of improving mean hemoglobin change from baseline to week six vs. placebo (p=0.0004, p<0.0001 and p<0.0001, respectively).

The last 10 weeks of the 16-week trial consisted of a dose adjustment and maintenance period. Secondary endpoints include time to reach target hemoglobin level from baseline, mean change in hemoglobin between pretreatment and the end of the dose adjustment and maintenance period, need for red blood cell transfusion or rescue with an erythropoiesis-stimulating agent (ESA) and safety...