Keryx Biopharma Begins Phase 3 Trial Of Ferric Citrate - Quick Facts

(RTTNews) - Keryx Biopharmaceuticals, Inc. (KERX) Monday said it has begun its pivotal Phase 3 trial of Ferric Citrate, as a treatment for iron deficiency anemia in patients with non-dialysis dependent (Stage 3-5) chronic kidney disease. The Phase 3 study is a multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period, followed by an 8-week open-label safety extension period in which all subjects receive Ferric Citrate, for a total of 24 weeks. Currently, there are no oral iron formulations that are FDA approved for the treatment of iron deficiency anemia in CKD patients. Earlier, on September 5, the U.S. Food and Drug Administration or FDA had approved Ferric Citrate for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.