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Rockwell Medical Inc Announces Iron Delivery Drug SFP Meets Primary Endpoint In PRIME Clinical Study


Monday, 4 Feb 2013 07:30am EST 

Rockwell Medical Inc announced topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), 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. 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. 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. 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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