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Zerenex™ (ferric citrate) long-term Phase 3 study results published in JASN
Date:7/24/2014

ferritin and TSAT.

The results showed Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in serum ferritin (+306 ng/mL vs. +19 ng/mL) and TSAT (+8% vs -1.2%) from baseline (day 0) to week 52. In the PERFECTED study, subjects randomized to receive Zerenex required significantly lower dosages of IV iron and ESA; and hemoglobin levels were higher in Zerenex treated patients than in those receiving active control.

The investigators cited an analysis of the trial results that indicated that the projected reduction in the need for IV iron and ESA use would result in significant pharmaco-economic benefits. In addition, the investigators wrote, "one would postulate that decreased IV iron and ESA usage could result in decreased nursing time to administer IV medications which could be redirected to other aspects of patient care and decreased risk of infections due to fewer IV injections." In the PERFECTED study, fewer serious adverse events (SAEs) due to infection were seen in the subjects randomized to Zerenex compared to active control.

The authors noted that, if approved, Zerenex would be the only phosphate binder that also increases iron stores and decreases IV iron and ESA use.

Study Design and Results

Subjects in the PERFECTED study (n=441) first entered a 2-week washout period and were then randomized in a 2:1 ratio to receive either Zerenex or an active control of Renvela (sevelamer carbonate) and/or Phoslo (calcium acetate) for a 52-week Active Control Period. This was then followed by a 4-week Placebo Control Period in which Zerenex subjects were again randomized to either continue on Zerenex or switch to placebo. Zerenex was administered as 1 gram tablets each containing 210 mg of ferric iron. Active control study drugs were administered as calcium acetate 667 mg capsules, sevelamer carbonate 800 mg tablets alone or in combination.

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Contact: Amy Sullivan
amy.sullivan@keryx.com
617-466-3447
Keryx Biopharmaceuticals, Inc.
Source:Eurekalert

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