Atlanta, GA 4/30/12 (StreetBeat) -- 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 today that it has completed patient enrollment in its PRIME clinical study, which is designed to investigate the reduction in the need for erythropoietin stimulating agents (ESA) in hemodialysis patients receiving Soluble Ferric Pyrophosphate (SFP) via dialysate.Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are excited to achieve another important milestone in our SFP clinical development. The PRIME study is expected to generate compelling clinical data that we anticipate will differentiate SFP as an advanced iron-delivery therapy for hemodialysis patients, once FDA approved."
The PRIME study is a nine-month, multi-center study randomizing 100 patients equally to dialysate containing SFP-iron versus conventional dialysate. The primary objective of the study is to determine whether regular administration of SFP-iron via dialysate reduces the requirement for erythropoietin stimulating agents (ESAs) by maintaining iron balance and optimizing iron delivery. The primary end point is percent change from baseline in ESA dose required to maintain Hgb in the target range. Secondary endpoints include ESA response index (ERI), measures of oxidative stress, hemoglobin variability and amount of supplemental intravenous iron needed.
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