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ARTICLE | Clinical News

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

October 20, 2017 12:30 AM UTC

Akebia Therapeutics Inc. (NASDAQ:AKBA) said oral vadadustat met the primary endpoint of improving mean hemoglobin levels in a Phase II trial to treat anemia in non-dialysis-dependent patients with chronic kidney disease (CKD). Top-line data from the double-blind, Japanese trial in 51 patients showed that once-daily 150 (p<0.0045), 300 (p<0.0001) and 600 mg (p<0.0001) doses of vadadustat each significantly improved mean hemoglobin levels from baseline to week 6 vs. placebo. Akebia said the data indicate a "dose response."

The last 10 weeks of the 16-week trial consisted of a dose adjustment and maintenance period. The trial’s 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...