Akebia Therapeutics and U.S. Renal Care Initiate the VOICE Trial of Vafseo® (vadadustat) for Patients on Dialysis

Core Insights - Akebia Therapeutics and U.S. Renal Care are initiating a clinical trial for Vafseo to assess its impact on mortality and hospitalization in patients with chronic kidney disease [1][2] - The VOICE trial aims to enroll approximately 2,200 patients, comparing Vafseo to standard erythropoiesis-stimulating agents [2] - The trial's primary endpoint is all-cause mortality, while the secondary endpoint focuses on all-cause hospitalization, with a goal of demonstrating non-inferiority for mortality and superiority for hospitalization reduction [2][3] Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4] - U.S. Renal Care is the largest privately held dialysis provider in the U.S., serving over 36,000 patients across 32 states since its establishment in 2000 [5] Product Information - Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoietin production to manage anemia in chronic kidney disease patients on dialysis [6][7] - Vafseo is approved for use in 37 countries and is indicated for adults receiving dialysis for at least three months [6][7] Clinical Trial Details - The VOICE trial will randomize patients to receive either oral Vafseo 300 mg three times per week or standard care agents, concluding approximately 18 months after the last patient is enrolled [2] - The trial is designed to provide real-world evidence regarding the safety and efficacy of Vafseo in alignment with patients' dialysis schedules [3]