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Rockwell Medical Inc Announces PRIME Study Results At The 50th ERA-EDTA Meeting In Istanbul


Monday, 20 May 2013 08:00am EDT 

Rockwell Medical Inc announced PRIME clinical study results for Soluble Ferric Pyrophosphate (SFP) at the 50th ERA-EDTA congress in Istanbul. SFP is the Company's investigational iron-delivery drug for the treatment of iron deficiency in hemodialysis patients, nearing completion of its Phase 3 clinical studies. This is fully-analyzed data, including atypical data subsequently found in a few study subjects, superseding initial top-line data announced Feb 4, 2013. 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. 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 iron was administered according to a protocol to treat iron deficiency. The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). 

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