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 design
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 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 ANALYSES
The 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 endpoint, with the regression analysis
indicating a highly statistically significant dose response (p