Phase III results with Auryxia/Fexeric (ferric citrate) for iron deficiency anemia published in JASN- Keryx Biopharmaceuticals
Keryx Biopharmaceuticals announced the publication of results from its pivotal Phase III study evaluating Auryxia/Fexeric (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). The article describes previously reported Phase III results, in which ferric citrate achieved statistically significant results on the primary and all five pre-specified secondary endpoints for the treatment of IDA in adults with NDD-CKD versus placebo.
Patients enrolled in the trial had not adequately responded to or could not tolerate prior treatment with oral iron. In the Phase III study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event.
See: "Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia" Steven Fishbane et al. JASN ASN.2016101053; published ahead of print January 12, 2017, doi:10.1681/ASN.2016101053