Rockwell Medical announced today that it has commenced enrollment in its clinical study designed to investigate reduction in the need for erythropoietin stimulating agents in hemodialysis patients receiving Soluble Ferric Pyrophosphate (SFP) via dialysate.

The PRIME study, a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study will randomize 100 patients equally to dialysate containing SFP-iron versus conventional dialysate.

In all study patients, ESA dose may be titrated to maintain hemoglobin in the target range and intravenous iron may be administered as needed to maintain iron balance. The primary objective of the study is to determine whether regular administration of SFP via the dialysate reduces the requirement for erythropoietin stimulating agents 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.  Results of the PRIME study are expected mid-2012.

Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are excited to initiate the PRIME study. The study is expected to generate compelling clinical and marketing data using a design that mirrors clinical practice. Demonstrating ESA sparing should differentiate SFP as a superior choice for iron-maintenance therapy in chronic hemodialysis patients, once FDA approved."