Akebia Therapeutics and U.S. Renal Care Launch VOICE Trial of Vafseo® for Dialysis Patients

Akebia Therapeutics, Inc., a biopharmaceutical company focused on kidney disease, and U.S. Renal Care (USRC), the largest privately held kidney care provider in the U.S., have announced a collaborative clinical trial for their recently approved anemia drug, Vafseo. This study, known as the VOICE (Vafseo Outcomes In-Center Experience) trial, will enroll approximately 2,200 patients. These participants will be randomly assigned to receive either oral Vafseo 300 mg tablets three times a week or the standard erythropoiesis-stimulating agents, with the trial expected to conclude around 18 months after the last patient is randomized.

The primary goal of the VOICE trial is to measure all-cause mortality, while the secondary goal is to assess all-cause hospitalization. The trial aims to demonstrate non-inferiority in terms of mortality and superiority in achieving a 10% reduction in hospitalization rates. The trial's design builds on existing evidence of Vafseo's safety and efficacy from prior studies, such as the INNO2VATE, MO2DIFY, and FO2CUS trials.

Steven K. Burke, M.D., Chief Medical Officer of Akebia, expressed enthusiasm about partnering with U.S. Renal Care for this important trial. He emphasized the importance of understanding the safety and benefits of Vafseo when administered three times a week, which aligns with the current dialysis schedule of patients. Burke added that Akebia is focused on providing an oral treatment option for anemia that could offer enhanced hemoglobin stability for kidney patients.

Geoffrey A. Block, M.D., FASN, Associate Chief Medical Officer and Senior Vice President of Clinical Research & Medical Affairs for U.S. Renal Care, echoed this sentiment. He noted that the VOICE trial represents a significant step in potentially establishing Vafseo as a new standard of care for anemia due to chronic kidney disease. Block highlighted the importance of generating real-world evidence to understand the full spectrum of benefits and risks associated with Vafseo, thereby providing valuable insights for both physicians and patients.

Akebia Therapeutics, founded in 2007 and headquartered in Cambridge, Massachusetts, is dedicated to improving the lives of people affected by kidney disease. The company is fully integrated and has a strong focus on clinical research and development.

U.S. Renal Care, founded in 2000, is the largest privately held dialysis provider in the nation, operating in 32 states and serving over 36,000 patients. The organization is committed to clinical quality, innovation, and operational excellence.

Vafseo (vadadustat) tablets are an oral treatment designed to manage anemia by stimulating the body's production of erythropoietin, thereby increasing hemoglobin and red blood cell levels. Approved in 37 countries, Vafseo is indicated for the treatment of anemia in adults with chronic kidney disease who have been on dialysis for at least three months. However, it is not intended as a substitute for red blood cell transfusions or for use in patients with anemia due to chronic kidney disease who are not on dialysis.

The safety profile of Vafseo includes warnings about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access if hemoglobin levels rise too quickly. It also has potential hepatotoxic effects and can exacerbate hypertension. Other serious adverse reactions include seizures and gastrointestinal erosions. The drug is not recommended for patients with active malignancies, serious acute kidney injury, or acute liver disease.

In summary, the VOICE trial aims to provide crucial real-world data on Vafseo, potentially establishing it as a new standard of care for anemia in chronic kidney disease patients undergoing dialysis. Both Akebia Therapeutics and U.S. Renal Care are committed to advancing treatment options and improving patient outcomes in this field.

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