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Keryx Biopharmaceuticals Announces Highly Statistically Significant Positive Results From Phase 3 Study Of Zerenex
6:00am EST
Keryx Biopharmaceuticals announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex (ferric citrate), 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 on dialysis. In this study, conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), Zerenex met the study's primary endpoint, demonstrating a highly statistically significant dose response. In addition, key secondary endpoints were also met with high statistical significance. This Phase 3 study was a multicenter, randomized, open-label trial with a two-week washout period, following which patients were randomized 1:1:1 to receive a fixed dose of Zerenex of either one gram, six grams or eight grams per day for a treatment period of 28 days. Zerenex was administered using a one gram oral caplet formulation, hence, the fixed-dose arms of one gram, six grams and eight grams per day represent one, six and eight pills per day, respectively. One hundred fifty-one dialysis patients were enrolled into the study. The Intent-to-Treat (ITT) group included 146 patients, 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.
