It did this by increasing levels of hemoglobin and improving iron mobilization in CKD patients with anemia, compared with a placebo. Hemoglobin is an oxygen-carrying, iron-containing molecule in red blood cells.
The results of the trial were published in the American Journal of Nephrology under the title “Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease.”
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer. Akebia is developing it at a time when few options are available for treating CKD-related anemia.
Anemia is a condition in which the body has fewer red blood cells than normal. Red blood cells carry oxygen to tissues and organs throughout the body, enabling them to obtain energy from food, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
Anemia is common in people with CKD. It can begin developing in the early stages of CKD, when someone has 20 to 50 percent of normal kidney function, and tends to worsen as the disease progresses.
The results Akebia announced came from a multicenter, six-week, randomized, double-blind, placebo-controlled, Phase 2a clinical trial (NCT01381094). It evaluated the effectiveness, safety, and tolerability of oral vadadustat in pre-dialysis CKD patients with anemia. Pre-dialysis patients are in Stage 3 or 4 of CKD.
The 92 patients in the six-week trial were randomly assigned to one of five groups. The first four received either 240, 370, 500, or 630 mg doses of vadadustat per day. The other group received a placebo.
Patients who took vadadustat showed significant increases in hemoglobin levels, compared with those who took a placebo. And the higher the dose of vadadustat, the more increase in hemoglobin.
Vadadustat also increased CKD patients’ iron-binding capacity and decreased their concentrations of ferritin and hepcidin, proteins that play vital roles in iron metabolism and are markers for anemia.
In terms of safety, the number of patients who experienced at least one treatment-related adverse event was similar between the vadadustat and placebo groups. There were no significant changes in blood pressure, vascular endothelial growth factor, C-reactive protein, or total cholesterol.
“This Phase 2a publication further demonstrates the potential of vadadustat to set a new standard of care in renal anemia and provides a strong basis for our global Phase 3 program, which continues to enroll CKD patients in both the non-dialysis and dialysis-dependent setting,” Brad Maroni, MD, the chief medical officer of Akebia, said in a press release.
A Phase 3 clinical trial program evaluating vadadustat is continuing in both non-dialysis-dependent and dialysis-dependent patients with CKD-related anemia.