Akebia Announces Positive Topline Results From Phase 4 Study On Auryxia

(RTTNews) - Akebia Therapeutics, Inc. (AKBA) Thursday announced positive results from its Phase 4 collaborative study, IMPACT, which examined the effects of Auryxia or ferric citrate as the primary therapy for lowering phosphate levels in adult patients with chronic kidney disease or CKD on dialysis.

The study investigated the impact of Auryxia on the utilization of erythropoiesis-stimulating agents or ESA and intravenous or IV iron, as well as its effects on phosphate and anemia management compared to the standard of care or SOC.

The patients were randomized into two groups, with one group receiving Auryxia of 6 tablets per day and the other remaining on SOC, which consisted of non-Auryxia phosphate-lowering agents. The study duration was up to 6 months.

Akebia said the co-primary endpoints of the study were the difference in monthly ESA and IV iron doses between the two groups during the efficacy evaluation period. The secondary endpoints included the proportion of patients with serum phosphate levels =5.5 mg/dL and hemoglobin levels =10.0 g/dL during the same evaluation period.

The company noted that three patients discontinued Auryxia due to gastrointestinal intolerance or adverse events, while serious adverse events were reported in 39% of patients receiving Auryxia and 59% in the SOC group.

IMPACT, sponsored by U.S. Renal Care Kidney Research in collaboration with Akebia, enrolled 209 adult patients with CKD receiving in-center or home dialysis.