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Home » Keryx completes patient enrollment for phase III Zerenex trial

Keryx completes patient enrollment for phase III Zerenex trial

September 19, 2011
CenterWatch Staff

Keryx Biopharmaceuticals has completed patient enrollment in the long-term study component of its phase III registration program of Zerenex, the company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The Zerenex phase III registration program, which is being conducted pursuant to a Special Protocol Assessment (SPA) with the FDA, is comprised of an already successfully-completed phase III short-term study, and this ongoing phase III long-term study.

This phase III long-term study is a multicenter, randomized, open-label, safety and efficacy clinical trial in over 400 ESRD patients on hemodialysis or peritoneal dialysis. The study consists of a 2-week washout period followed by a 52-week safety assessment in which patients are randomized 2:1 to receive either Zerenex or an active control. The 52-week safety assessment period is followed by a 4-week efficacy assessment.  During the 4-week efficacy assessment, only those patients randomized to treatment with Zerenex during the safety assessment period will be randomized in a 1:1 ratio to either continue treatment with Zerenex or to be switched to placebo for a 4-week period.

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