Keryx Biopharmaceuticals has announced positive final results from the Phase II multicenter study of the effects of Zerenex on serum phosphate in patients with end stage renal disease (ESRD). The Phase II trial was conducted under an IND (investigational new drug) application sponsored by the company's licensors in the U.S. and Taiwan.
The study was designed to determine the safety and efficacy of several doses of Zerenex in patients with end stage renal disease who were undergoing hemodialysis. In this study, each of three Zerenex doses (2 g, 4 g and 6 g) administered daily with meals was compared to placebo. Patients who had been on other phosphate binders prior to enrolling in this study underwent a 1-2-week washout period prior to randomization.