Akebia reports Phase 4 results of Auryxia for dialysis patients

Akebia Therapeutics announced topline results from IMPACT, a Phase 4 collaborative study investigating the impact of Auryxia when used as the primary phosphate-lowering therapy, on the utilization of erythropoiesis-stimulating agent – ESA – and intravenous iron as well as on laboratory parameters indicative of phosphate and anemia management vs. the standard of care in adult patients with chronic kidney disease – CKD – on dialysis. Auryxia is approved for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. Co-primary endpoints were the difference in mean change from baseline to the efficacy evaluation period in monthly ESA and IV iron doses between groups. Treatment with Auryxia resulted in a statistically significant difference in mean monthly ESA use and a non-significant difference in mean monthly IV iron use. Serious adverse events occurred in 39% of patients receiving Auryxia and 59% in those receiving SOC.