Keryx Biopharmaceuticals Initiates Phase 2 Study of Zerenex for the Treatment of Non-Dialysis Dependent Chronic Kidney Disease

07-Nov-2012 - USA

Keryx Biopharmaceuticals, Inc. announced 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 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.

https://www.bionity.com/en/news/140393/keryx-biopharmaceuticals-initiates-phase-2-study-of-zerenex-for-the-treatment-of-non-dialysis-dependent-chronic-kidney-disease.html