NEW YORK, Nov. 1, 2012 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 2 study of Zerenex ™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease ("NDD-CKD"). In the United States alone, over one and a half million people suffering from Stages 3 to 5 NDD-CKD have iron deficiency anemia, however, there are currently no oral iron supplements with an FDA label in NDD-CKD. Also, there are currently no FDA approved phosphate binders in NDD-CKD.
The Phase 2 study initiated today is a multicenter, randomized, safety and efficacy clinical trial designed to compare the ability of Zerenex to manage serum phosphorus and iron deficiency versus placebo in anemic patients with Stages 3 to 5 NDD-CKD. Eligible patients will be randomized 1:1 to receive either Zerenex or placebo for a 12-week treatment period. The primary endpoints of the study are to demonstrate changes in ferritin, TSAT and serum phosphorus levels over the 12-week treatment period. Secondary endpoints include changes in hemoglobin and FGF-23. The study plans to randomize approximately 150 patients from approximately 15 sites in the U.S. Patient enrollment is expected to take up to 6 months, with study completion expected in mid-2013.
The study's three Co-Chairmen are:
- Geoffrey A. Block, MD, Director of Clinical Research at Denver Nephrology and Associate Clinical Professor in Medicine at the University of Colorado Health Sciences Center;
- Glenn Chertow, MD, Chief, Division of Nephrology and Professor of Medicine at Stanford University School of Medicine; and
- Steven Fishbane, MD, Vice President of North Shore-LIJ Health System for Network Dialysis Services and Director of Clinical Research at North Shore-LIJ Department of Medicine.
Dr. Block commented, "I am pleased to be leading this study for Zerenex. Several studies, including the REIN and ARIC studies, have demonstrated that elevated serum phosphorus is a predictor of morbidity and mortality in NDD-CKD. Therefore, I believe that additional clinical trials aimed at controlling serum phosphorus in NDD-CKD are important. I further believe that with Zerenex's potential to also address iron deficiency, it could become an important agent in the NDD-CKD setting."