Keryx Biopharmaceuticals announced positive final data from its Phase 3 study of Zerenex (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease (ESRD) patients on dialysis. This multicenter, randomized, open-label trial, with a two-week washout period, randomized patients in a 1:1:1 ratio to receive a fixed dose of Zerenex of 1gm, 6gm or 8gm per day for a treatment period of 28 days. Of the total 151 dialysis patients that were enrolled in the study, 146 patients were included in the intent-to-treat (ITT) group, representing all patients who took at least one dose of Zerenex and provided a baseline (at the end of washout) and at least one post-baseline efficacy assessment. The study met its primary endpoint, which was to determine whether there was a dose response in the change in serum phosphorus from baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.
Zerenex is an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes.
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