Vitamin Deficiency

February 11, 2013

Rockwell Medical issues results from a phase III trial of soluble ferric pyrophosphate (SFP) for the treatment of iron deficiency. This nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study, PRIME, enrolled 108 hemodialysis patients with an iron deficiency. Subjects received either a dialysate containing SFP-iron or a conventional dialysate. Results showed the SFP dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% (p=0.034) while maintaining iron balance and maximizing iron delivery, compared to the conventional dialystate. The ESA sparing effect from SFP was observed without an increase in serum ferritin or transferrin saturation. The drug was well tolerated. Discontinuations due to adverse events were two in SFP and three in conventional dialysate and were similar between treatment groups. Further analysis of the complete data set is ongoing and Rockwell Medical plans to submit PRIME data results for presentation at a major medical meeting later in 2013.