Keryx Biopharmaceuticals Inc. has begun a Phase 3 study of Ferric Citrate to treat irondeficiency anemia in patients with non-dialysis dependent (Stage 3-5) chronic kidney disease.
On Sept. 5, 2014 the U. S. Food and Drug Administration approved Ferric Citrate to control serum phosphorus levels in patients with chronic kidney disease on dialysis.
“We are encouraged by the positive results observed in our Phase 2 study in this patient population and we believe that the study commencing today, if successful, will support indication expansion for Ferric Citrate,” said CEO Ron Bentsur.
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. Approximately 230 subjects, who have previously had an inadequate response to oral iron supplements, will be randomized into the randomized period in a 1:1 ratio to receive either Ferric Citrate or matching placebo. Intravenous iron and erythropoiesis-stimulating agent use is prohibited during and leading up to the study.
The study’s co-chairmen are Geoffrey Block, MD, director of clinical research at Denver Nephrology; Glenn Chertow, MD, professor of medicine and chief of the division of nephrology atStanford University School of Medicine; and Steven Fishbane, MD, division chief of the kidney disease and hypertension division at North Shore University Hospital/Long Island Jewish Medical Center. The study will be conducted at approximately 40 sites in the U.S.
“As CKD progresses, the prevalence of iron deficiency anemia increases. It is estimated that there are well over 1.5 million CKD stages 3-5 patients with iron deficiency anemia,” said Fishbane. “If approved in this indication, Ferric Citrate could represent a viable treatment option for these patients.”