Keryx Biopharmaceuticals, Inc. announced the publication of results from its pivotal Phase 3 study evaluating ferric citrate for iron deficiency anemia (IDA) in non-dialysis-dependent chronic kidney disease (NDD-CKD) in the online issue of the Journal of the American Society of Nephrology (JASN). Ferric citrate (Auryxia®) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis. Data in the publication highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD. Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia.  Efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens. The pivotal Phase 3 study randomized 234 patients (233 patients received at least one starting dose of ferric citrate) at 32 clinical sites in the United States. NDD-CKD patients with hemoglobin levels between 9.0 g/dL and 11.5 g/dL and who were intolerant to or had inadequate response to oral iron supplements were randomized 1:1 (ferric citrate versus placebo), n=117 and n=116, respectively. Patients enrolled in the study were not allowed to receive any IV or oral iron, or ESAs during this study. The study had a 16-week, randomized, double-blind, placebo-controlled, efficacy period followed by an 8-week open-label safety extension period in which all patients remaining in the study, including the placebo group, received ferric citrate. During the 16-week efficacy period, ferric citrate was administered at a starting dose of three tablets per day with food and could be titrated every four weeks by an additional three tablets for up to a maximum of 12 tablets per day; the mean dose received in ferric citrate treated patients was 5 tablets per day. The primary endpoint was the proportion of patients achieving a =1 g/dL increase in hemoglobin at any point during the 16-week efficacy period. Baseline laboratory values were similar between the treatment arms. Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious.