Akebia Presents Results from its PRO2TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis During Late-Breaking Session at American Society of Nephrology Kidney Week 2020 Reimagined

CAMBRIDGE, Mass., Oct. 23, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced the presentation of clinical data from its PRO2TECT global Phase 3 program that evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis, at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week). As previously announced, vadadustat achieved the primary and key secondary efficacy endpoints in each of the two studies in the program, but did not meet the primary safety endpoint. Newly presented pre-specified regional analyses of the PRO2TECT program show vadadustat demonstrated no clinically meaningful increase in cardiovascular risk compared to darbepoetin alfa in analyses of MACE, expanded MACE and all-cause mortality in U.S. patients treated to a target hemoglobin (Hb) range of 10 to 11 g/dL, consistent with U.S. treatment guidelines.stats

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