Keryx Biopharmaceuticals is focused on medically important pharmaceutical products for the treatment of renal disease. The company is currently developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes.
The company today announced the initiation of a Phase 2 study of Zerenex 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 U.S. alone, over 1.5 million people suffering from Stages 3-5 NDD-CKD have iron deficiency anemia. However, there are currently no oral iron supplements with an FDA label nor are there any FDA-approved phosphate binders.
The Phase 2 study started today is a multi-center, 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. The study plans to randomize about 150 patients in approximately 15 sites in the U.S.
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 of the study include changes in hemoglobin and FGF-23. Study completion is expected sometime in mid-2013.
Zerenex is also in a long-term Phase 3 study, under Special Protocol Assessment, as a treatment for end-stage renal disease patients with hyperphosphatemia on dialysis. Top-line data from this study is expected to be announced around year-end. The NDA filing is expected to occur in the first quarter of 2013 for this indication.
For further information about Keryx Biopharmaceuticals and its Zerenex product, please visit www.keryx.com
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