Keryx Biopharmaceuticals Announces Zerenex(TM) (ferric citrate coordination complex) Meets All Primary and Key Secondary Endpoints in Phase 2 Study of Non-Dialysis Dependent Chronic Kidney Disease Patients With Elevated Serum Phosphorus and Iron Deficiency Anemia
NEW YORK, Nov. 5, 2013 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (KERX) today announced successful top-line results from its Phase 2 study of Zerenex(TM) (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia. In this study, Zerenex met both co-primary endpoints, described below, demonstrating highly statistically significant changes in serum phosphorus and transferrin saturation (TSAT) versus placebo over the 12-week treatment period. In addition, Zerenex met the key secondary endpoints of increasing ferritin and hemoglobin, and decreasing fibroblast growth factor-23 (FGF-23) versus placebo. The Company plans to meet with the Food and Drug Administration (FDA) to discuss these data with the goal of defining a path forward towards obtaining a labeled indication for the treatment of iron deficiency anemia in NDD-CKD patients.
The Co-Chairmen of the study were Geoffrey A. Block, MD, Director of Clinical Research at Denver Nephrology; Glenn Chertow, MD, Chief, Division of Nephrology and Professor of Medicine at Stanford University School of Medicine; and Steven Fishbane, MD, Chief, Division of Nephrology, Vice President of North Shore-LIJ Health System for Network Dialysis Services and Director of Clinical Research at North Shore-LIJ Department of Medicine.
Study Design
This Phase 2 study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with stage 3 to 5 NDD-CKD, with elevated serum phosphorus >=4.0 mg/dL and iron deficiency anemia. The study consisted of a 2-week washout period (for subjects on a phosphate binder at screening) followed by a 12-week treatment period in which subjects were randomized 1:1 to receive either Zerenex or placebo. One hundred forty-nine (149) subjects were randomized into the study from 20 sites in the United States.
The use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) were not permitted within 8 weeks and 4 weeks prior to the study, respectively, and not permitted during the course of the study. Oral iron therapy was also not permitted during the course of the study.
Co-Primary and Key Secondary Endpoints
Zerenex met both co-primary and all key secondary endpoints with highly statistically significant results.
The Intent-to Treat (ITT) group included 141 subjects, representing all subjects who took at least one dose of Zerenex or placebo and provided at least one post-baseline efficacy assessment.
The co-primary efficacy endpoints of this trial were the mean changes in serum phosphorus and TSAT from baseline to the end of the 12-week treatment period versus placebo in the ITT group.
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