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Akebia Therapeutics and U.S. Renal Care Initiate the VOICE Trial of Vafseo® (vadadustat) for Patients on Dialysis
Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of careTrial aims to build a body of
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of careTrial aims to build a body of real-world evidence to understand the potential benefits of treating patients with VafseoCAMBRIDGE, Mass., Sept. 5, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and U.S. Renal Care (USRC), the nation's largest privately held and fastest-growing kidney care provider, today announced plans to begin a collaborative clinical trial of recently approved Vafseo. The first patient in this trial is expected to be enrolled this year.\n\n \n \n \n \n \n \n\n \nThe Vafseo Outcomes In-Center Experience (VOICE) trial intends to enroll approximately 2,200 patients who will be randomized to oral Vafseo 300 mg tablets administered three times per week or standard-of-care erythropoiesis-stimulating agents. The trial will end approximately 18 months after the last patient is randomized. The primary endpoint is all-cause mortality and the secondary endpoint is all-cause hospitalization. The trial was powered to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization. More information about the VOICE trial can be found here.\n\"We are pleased to be collaborating with the prominent kidney care provider, U.S. Renal Care, on this important trial. Akebia has already established a robust body of evidence with respect to the safety and efficacy of Vafseo in dialysis patients with the INNO2VATE clinical trial program, as well as its MO2DIFY and FO2CUS studies,\" said Steven K. Burke, M.D., Chief Medical Officer of Akebia. \"Given what we have learned, we are excited to collaborate with U.S. Renal Care on the VOICE trial to further investigate the safety of Vafseo when dosed three times a week to align with patients' current dialysis schedule. We continue to focus on helping those kidney patients who may benefit from an orally-administered treatment for anemia that leads to enhanced hemoglobin stability.\"\n\"U.S. Renal Care is proud to be spearheading the first Vafseo patient experience trial in our dialysis centers,\" noted Geoffrey A. Block, M.D., FASN, Associate Chief Medical Officer and Senior Vice President, Clinical Re...