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

primary end-point of this trial was the mean change in serum phosphorus from baseline (Week 52) to the end of the 4-week Placebo Control Period. A prospectively designed sequential gatekeeping strategy controlled study-wise type 1 error for serum ferritin, TSAT, IV iron and ESA usage as pre-specified secondary endpoints in the 52-week Active Control Period.

The primary end-point demonstrated mean serum phosphorus was lower in the ferric citrate group versus the placebo group with a mean treatment difference of -2.2 0.2 mg/dL (P <0.0001) at the end of the 4-week Placebo Control Period. The results demonstrated increased serum ferritin (P<0.0001) and TSAT (P<0.0001) compared to active control; decreased IV iron usage (P<0.0001) and decreased ESA usage (P=0.04). Additionally, mean hemoglobin levels were higher in subjects treated with Zerenex compared to active control (P=0.018) over 52 weeks.

Zerenex appeared safe and well tolerated in this study. Serious and non-serious adverse events (AE's) were similar between the two groups (Zerenex 90.3%, active control 89.3%), with the most common adverse events gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. Adverse events were generally characterized as mild to moderate in nature. Serious adverse events were reported in 39.1% of subjects receiving Zerenex and 49.0% of active control subjects. Of interest, fewer SAE's were reported in the Zerenex group compared to the active control group in the categories of infection, cardiovascular and gastrointestinal (MEDRA terms). In addition, there were no clinically or statistically-significant differences in liver enzymes or aluminum levels between the treatment arms.


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

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