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Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients
CAMBRIDGE, Mass., June 29, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., June 29, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced topline results from IMPACT, a Phase 4 collaborative study investigating the impact of Auryxia® (ferric citrate), when used as the primary phosphate-lowering therapy, on the utilization of erythropoiesis-stimulating agent (ESA) and intravenous (IV) iron as well as on laboratory parameters indicative of phosphate and anemia management compared to the standard of care (SOC) 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.\n\n \n \n \n \n \n \n\n \nIMPACT, sponsored by U.S. Renal Care Kidney Research in collaboration with Akebia, was a randomized, open-label, active-controlled, multicenter study in adult patients with CKD receiving either in-center hemodialysis or home dialysis. The study enrolled 209 adult patients who were randomized 1:1 to Auryxia (starting dose of 6 tablets per day) or to remain on SOC, defined as non-Auryxia phosphate-lowering agent, for up to 6 months. The two groups had generally similar baseline characteristics with the exception of atherosclerotic cardiovascular disease and congestive heart failure, which were more common in the SOC group.\nCo-primary endpoints were the difference in mean change from baseline (month -3 to Day 1) to the efficacy evaluation period (months 4-6) in monthly ESA and IV iron doses between groups. Secondary endpoints were the difference in the proportion of patients with serum phosphate ≤5.5 mg/dL and hemoglobin (Hb) ≥10.0 g/dL, during the efficacy evaluation period (months 4-6). Treatment with Auryxia resulted in a statistically significant difference in mean monthly ESA use (-30.82 mcg/month, P=0.02) and a non-significant difference in mean monthly IV iron use (-37.02 mg/month, P=0.17). There were similar proportions of patients in each group with Hb ≥10.0 g/dL and serum phosphate ≤5.5 mg/dL. \nThree patients stopped Auryxia due to gastrointestinal intolerance (n=2) or adverse events (n=1). Serious adverse events occurred in 39% ...