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U.S. Renal Care Presents Analysis of VOICE Trial Demonstrating Favorable Safety Outcomes for Patients Treated with Vadadustat Versus an ESA During a Late-Breaking Session at American Society of Nephrology Kidney Week

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  • U.S. Renal Care presented data from the VOICE trial at ASN Kidney Week 2026, showing vadadustat achieved significantly improved safety outcomes versus erythropoiesis-stimulating agents (ESA).
  • The trial demonstrated a statistically significant reduction in the composite primary endpoint of all-cause mortality and hospitalization, driven primarily by a 10% lower hospitalization rate with vadadustat compared to ESA.
  • Patients treated with vadadustat exhibited more stable hemoglobin control, with a 64% reduction in odds of hemoglobin excursions above 12 g/dL and a 57% reduction in excursions above 13 g/dL versus ESA.
  • Exposure-adjusted serious adverse events were lower for vadadustat (121.5 per 100 patient-years) compared to ESA (134.2 per 100 patient-years).
  • ESA rescue was 28% less likely in patients treated with vadadustat compared to those treated with ESA.
  • The VOICE trial enrolled 2,116 in-center hemodialysis patients in a randomized, open-label, active-controlled, noninferiority design.
  • Vadadustat (Vafseo) is a once-daily oral HIF-PHI approved by the FDA in March 2024 for anemia in adults with chronic kidney disease on dialysis for at least three months.
  • The trial found no statistically significant difference in mortality rates between vadadustat (8.8%) and ESA (8.8%) per 100 patient-years.
  • Vafseo carries a boxed warning for increased risks of death, myocardial infarction, stroke, venous thromboembolism, and vascular access thrombosis.
  • Targeting hemoglobin levels greater than 11 g/dL is expected to further increase the risk of death and thrombotic events.
  • Common adverse reactions occurring in at least 10% of patients were hypertension and diarrhea.
  • The drug is not indicated for anemia in patients not on dialysis due to observed increased risks of mortality, stroke, and serious acute kidney injury in that population.