Akebia Therapeutics Starts Phase 2 Study

Akebia Therapeutics said pre-market Wednesday it has dosed a first patient in a phase 2 study that will evaluate vadadustat in dialysis-dependent chronic kidney disease (DD-CKD) patients who are hyporesponsive to erythropoiesis-stimulating agents.

Specifically, the company said the phase 2 study will assess the safety and efficacy of vadadustat versus active comparator epoetin alfa in 80 DD-CKD patients with ESA hyporesponse in the US. The study’s primary outcome measure will be a percent reduction in previously-prescribed epoetin alfa dose and change in hemoglobin levels over the court of the study. The company expects to report data from the study by the end of 2018.

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