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U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis
Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care CAMBRIDGE, Mass., Dec. 3, 2024
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 care\nCAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that in late November U.S. Renal Care (USRC) enrolled the first patient in its Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial. Akebia announced the collaborative trial initiation in September 2024.\n\n \n \n \n \n \n \n\n \n\"We look forward to begin treating CKD anemia patients on dialysis with Vafseo ahead of its anticipated market launch in January 2025,\" said Steven K. Burke, M.D., Chief Medical Officer of Akebia. \"The study has been designed to evaluate Vafseo safety and efficacy when dosed three times a week to align with patients' current dialysis schedule as well as to explore additional potential patient benefits. We congratulate Dr. Geoff Block and his team at USRC on quickly consenting patients for the study and thank him for his commitment to patients impacted by kidney disease.\"\nVafseo was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is approved for once-daily oral administration and is expected to be available in the U.S. in January 2025.\nThe 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 non-inferiority for all-cause mortality and the secondary endpoint will test superiority of Vafseo to reduce all-cause hospitalization. More information about the VOICE trial can be found here.\nAbout U.S. Renal Care\nU.S. Renal Care partners with nephrologists across 32 states in the U.S. to care for more than 36,000 people living with kidney disease. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence – delivering the best experience and outcomes for our patients. For more information, visit USRenalCare.c...