Phase III PRO2TECT study of Vafseo meets primary endpoints in anemia due to chronic kidney disease.- Akebia Therapeutics

Akebia Therapeutics announced the presentation of clinical data from its PRO2TECT global Phase III program that evaluated the efficacy and safety of Vafseo (vadadustat), 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. As previously reported, vadadustat achieved the primary and key secondary efficacy endpoints in each of the two PRO2TECT studies, which demonstrated non-inferiority of vadadustat to darbepoetin alfa as measured by a mean change in Hb between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Non-inferiority was achieved as the lower bound of the 95% confidence interval for the between-group difference of the mean Hb change did not fall below the pre-specified non-inferiority margin (-0.75 g/dL). As previously reported, vadadustat did not meet the primary safety endpoint of the PRO2TECT program defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke across both PRO2TECT studies. The analysis of the primary safety endpoint used a Cox regression model that was pre-specified to be adjusted for certain variables, including age dichotomized >65 and 65 years and less. Data were presented at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week).