Cumulative IV iron Use

Each subject’s average cumulative IV iron intake was calculated over the 52-week Safety Assessment Period.  The ITT consisted of 278 subjects and 138 subjects for the Zerenex and active control groups, respectively.  Zerenex demonstrated a 51.6% decrease in median IV iron intake as compared to the active control group (p<0.0001).

Cumulative Erythropoiesis-Stimulating Agent (ESA) Use

Each subject’s average cumulative ESA intake was calculated over the 52-week Safety Assessment Period.  The ITT consisted of 280 subjects and 141 subjects for the Zerenex and active control groups, respectively.  Zerenex demonstrated a 27.1% decrease in median ESA intake as compared to the active control group (p=0.0322).
Mean Change in Hemoglobin

Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in hemoglobin from baseline (Day 0) to Week 52.
 

1  Last observation carried forward was used for missing data.

2  The LS Mean treatment difference and p-value is created via an ANCOVA model with treatment as the fixed effect and baseline as the covariate.

Safety and Tolerability Profile

For reference, subjects previously intolerant to Renvela® (sevelamer carbonate) and/or Phoslo® (calcium acetate) were ineligible to participate in this study.  Consistent with previous studies, Zerenex appeared safe and well tolerated in this study. Based on an analysis of safety data, the side-effect profile of Zerenex and the Active Control group appeared similar, with the most common adverse events gastrointestinal-related.  The overall rate of gastrointestinal-related adverse events, excluding feces discoloration which is an asymptomatic Zerenex side effect, were 39% Zerenex vs. 44% Active Control.  The most common gastrointestinal adverse events were: diarrhea, including soft stools (27% Zerenex vs. 14% Active Control), nausea (14% Zerenex vs. 14% Active Control), vomiting (9% Zerenex vs. 13% Active Control) and constipation (8% Zerenex vs. 5% Active Control). Adverse events were generally characterized as mild to moderate in nature.

The overall serious adverse event rates in the study were 34% Zerenex vs. 43% Active Control.  Importantly, there were no clinically meaningful or statistically significant differences between Z