NEW YORK, April 28, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals (Nasdaq: KERX) today announced the final dataset from the Phase 3 short-term clinical trial of Zerenex™ (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. The Zerenex data was presented earlier today at the National Kidney Foundation Spring Clinical Meetings being held in Las Vegas, Nevada, in an oral presentation by David S. Goldfarb, M.D., Clinical Chief of Nephrology, NYU Langone Medical Center, Professor of Medicine & Physiology, NYU School of Medicine. On November 30, 2010, the Company issued a press release announcing positive top-line results from this Phase 3 short-term study.
Phase 3 short-term study designThis 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 1 gram, 6 grams or 8 grams per day for a treatment period of 28 days. Zerenex was administered using a 1 gram oral caplet formulation, hence, the fixed-dose arms of 1 gram, 6 grams and 8 grams per day represent 1, 6 and 8 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. Efficacy assessments were taken weekly starting at Baseline and subsequently at days 7, 14, 21 and 28.
EFFICACY DATA ANALYSESThe primary endpoint of the study 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.
The study met the primary endp
|SOURCE Keryx Biopharmaceuticals, Inc.|
Copyright©2010 PR Newswire.
All rights reserved