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Rockwell Medical Announces Iron Delivery Drug SFP Meets Primary Endpoint in PRIME Clinical Study Demonstrating Statistically Significant 37% Reduction in ESA Dose
Date:2/4/2013

WIXOM, Mich., Feb. 4, 2013 /PRNewswire/ -- Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients. The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% while maintaining iron balance and maximizing iron delivery.

Study Design

The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study in United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate. A total of 103 patients received blinded study drug (52 SFP, 51 Placebo; modified ITT population). In each group, 11 subjects discontinued prematurely.  Discontinuations due to adverse events were 2 in SFP and 3 in placebo.  The reasons for the remaining discontinuations were similar between treatment groups.  The baseline hemoglobin was similar in both groups (10.9 g/dL SFP and 11.1 g/dL placebo).   In all study patients, ESA doses were titrated to maintain hemoglobin in a target range of 9.5 to 11.5 g/dL according to an algorithm managed by an independent centralized anemia management group.  At the end of treatment, the hemoglobin value in the SFP group was 10.5 g/dL and 10.4 g/dL in the placebo group.  Intravenous (IV) iron was adminis
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