Vadadustat for Anemia of Chronic Kidney Disease

(VOICE Trial)

This trial tests the safety of vadadustat, a new treatment for anemia in individuals with end-stage kidney disease undergoing hemodialysis. Anemia occurs when the body lacks enough red blood cells to carry oxygen, often causing extreme fatigue. The study compares vadadustat, taken three times a week, to standard treatments like EPOGEN or Aranesp. Ideal candidates for this trial are those on hemodialysis three times a week for end-stage kidney disease and who are already using or can use medications to boost red blood cells. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs like probenacid, rifampicin, gemfibrozil, or teriflunomide while participating.

Research has shown that vadadustat can safely increase hemoglobin (Hb) levels and help the body use iron more effectively in patients with chronic kidney disease (CKD) who have anemia. Importantly, it achieves this without causing many serious side effects. In previous studies, participants did not experience many serious problems when taking vadadustat.

Vadadustat is unique because it offers a fresh approach to treating anemia in chronic kidney disease by targeting the body's oxygen-sensing pathway. Unlike standard treatments like Epoetin alfa or Darbepoetin alfa, which stimulate red blood cell production directly, Vadadustat works by stabilizing a protein that encourages the body to produce its own erythropoietin naturally. This mechanism could potentially lead to more stable hemoglobin levels with fewer side effects. Researchers are excited because this method might reduce the need for frequent injections, providing a more convenient oral option for patients.

Research has shown that vadadustat, which participants in this trial may receive, can effectively raise hemoglobin levels in people with anemia caused by chronic kidney disease. Studies have found that vadadustat helps the body use iron better without causing more serious side effects than other treatments. This medication works by stabilizing a protein that aids in producing more red blood cells. Vadadustat has proven effective for patients both on dialysis and those who are not. Overall, patients using vadadustat have experienced improvements in managing anemia related to kidney disease.¹²³⁴⁶