U.S. Renal Care (USRC) has initiated the Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative clinical trial by enrolling its first patients in late November. This trial aims to evaluate the safety and efficacy of Vafseo in treating anemia due to chronic kidney disease (CKD) in adults undergoing dialysis for at least three months. Vafseo, approved by the U.S. Food and Drug Administration (FDA) in March 2024, is anticipated to be available in the U.S. market by January 2025.
Trial Design and Objectives
The VOICE trial is designed as an outcomes study comparing Vafseo to the current standard of care, erythropoiesis-stimulating agents (ESAs). Approximately 2,200 patients will be enrolled and randomized to receive either oral Vafseo 300 mg tablets three times per week or standard ESA treatment. The trial duration is expected to be around 18 months after the last patient is randomized. The primary endpoint is to demonstrate non-inferiority in all-cause mortality, while the secondary endpoint will assess Vafseo's superiority in reducing all-cause hospitalization.
Vafseo: A Novel Treatment for CKD-Related Anemia
Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It functions by activating the physiological response to hypoxia, stimulating the endogenous production of erythropoietin, which in turn increases hemoglobin levels and red blood cell production. This mechanism helps manage anemia in CKD patients. Vafseo is already approved for use in 37 countries.
Clinical Perspective
According to Steven K. Burke, M.D., Chief Medical Officer of Akebia, this study is designed to evaluate Vafseo's 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. The trial's design reflects an effort to integrate the treatment seamlessly into patients' existing dialysis routines, potentially improving adherence and outcomes.
Safety Considerations
The prescribing information for Vafseo includes a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. The warning emphasizes using the lowest effective dose to reduce the need for red blood cell transfusions and adhering to hemoglobin monitoring recommendations to avoid excessive erythropoiesis. Common adverse reactions include hypertension and diarrhea. Monitoring of liver function is also recommended during treatment.
