Clinical trial produces excellent safety results for kidney disease patients with anemia

A clinical trial led by UC Davis Health faculty found that a less frequent dosing schedule of the oral medication vadadustat (Vafseo) appears to be safe for patients who undergo kidney dialysis.

The oral medication was approved by the U.S. Food and Drug Administration in 2024 to treat anemia caused by chronic kidney disease in adults. The drug is currently approved for once-daily use.

The new trial evaluated the safety of administering it three times a week rather than daily, aligning treatment with a typical patient's dialysis clinic visits.

"Offering patients a treatment that aligns with their regularly scheduled dialysis sessions ensures adherence and reduces the burden of managing yet another medication at home," said Shuchi Anand, a kidney specialist and professor in the Department of Internal Medicine at UC Davis Health.

Anand served on the executive steering committee for the clinical trial, helping to design the study, oversee its implementation and evaluate its outcomes.

Need for new treatment options

Many patients on dialysis develop anemia because damaged kidneys produce less erythropoietin (EPO), the hormone that stimulates red blood cell production. Frequent blood draws and iron loss during dialysis sessions can further lower blood counts.

Treatment typically includes iron supplementation, EPO-stimulating injections and, more recently, oral medications to help reduce fatigue and prevent complications associated with low red blood cell levels.

"The goal of this trial was to broaden the range of treatment options available to patients," said Anand. "We haven't seen a new anemia therapy for people on dialysis in more than two decades. That makes it especially important to develop safe and effective alternatives."

Promising trial results

The clinical trial enrolled over 2,000 patients at more than 160 dialysis facilities nationwide. The trial compared a three-times-weekly oral treatment for anemia with the standard injectable therapy commonly used in dialysis patients.

Researchers evaluated the safety of the new approach by tracking patient outcomes, including hospitalizations and deaths.

The study met its primary goals: demonstrating that the oral treatment was at least as safe as standard therapy. Researchers also noted that patients receiving the oral medication experienced improved overall safety outcomes.

Based on the successful findings, an independent monitoring committee and the trial steering committee recommended ending the study early. The decision reflected the favorable safety profile observed among patients receiving the oral treatment.

"Dialysis is a burdensome therapy for patients," said Anand. "The scale and success of this trial should generate momentum for innovation and ultimately improve the quality of care for patients receiving dialysis."