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ARTICLE | Clinical News

Zerenex ferric citrate: Phase III data

February 4, 2013 8:00 AM UTC

Data from the intent-to-treat (ITT) population of 183 patients who received >=1 dose of Zerenex or placebo in the 4-week efficacy assessment of an open-label, international Phase III trial showed that oral Zerenex met the primary endpoint of reducing mean serum phosphorus levels from week 52 to week 56 vs. placebo (0.3 mg/dL vs. an increase of 1.9 mg/dL, p<0.0001). The trial, which enrolled 441 ESRD patients on hemodialysis or peritoneal dialysis, included a 52-week safety assessment comparing Zerenex to Renvela sevelamer carbonate and/or PhosLo calcium acetate followed by a 4-week, placebo-controlled efficacy assessment. In the efficacy assessment, only patients randomized to Zerenex during the safety assessment were re-randomized to continue treatment with Zerenex or switch to placebo.

Keryx also said that Zerenex met all key secondary endpoints. Specifically, Zerenex led to significant percent reductions in mean serum phosphorus concentration at weeks 12, 24, 36, 48 and 52 (27%, 29.7%, 29.7%, 28.4% and 28.4%, respectively) compared to baseline at day 0 (p<0.0001 for all). Zerenex also significantly increased mean ferritin (302 ng/mL (50.8%) vs. 9 ng/mL (1.5%), p<0.0001) and TSAT levels (25.8% vs. a 3.2% reduction, p<0.0001) from baseline at day 0 to week 52 vs. active controls. Additionally, Zerenex significantly reduced median IV iron intake by 51.6% (p<0.0001) and average cumulative ESA intake by 27.1% (p=0.0322) through week 52 as compared to active controls. Furthermore, Zerenex led to significantly lower decreases in mean hemoglobin from baseline at day 0 to week 52 vs. active controls (0.2 vs. 0.6 g/dL, p=0.0105). Zerenex was well tolerated. The adverse event profile was similar between Zerenex and the active control groups, with the most common adverse events being gastrointestinal-related. There were no clinically meaningful or significant differences between the Zerenex and active control groups in serum calcium levels or liver enzymes. Keryx has an SPA from FDA for the trial. ...

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