Rockwell Medical announced topline results for the PRIME clinical study of soluble ferric pyrophosphate (SFP), its investigational iron–delivery drug in a Phase 3 study for the treatment of iron deficiency in hemodialysis patients. SFP is an iron compound delivered to hemodialysis patient via dialysate replacing the 5–7mg of iron lost during a dialysis treatment.
The study was a nine–month, prospective, randomized, placebo–controlled, double–blinded, multi–center study which randomized 108 patients equally to dialysate containing SFP–iron vs. conventional dialysate. 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 % change in ESA dose from baseline to end of treatment (final two weeks of treatment period).
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 difference between the SFP arm and the placebo arm was statistically significant (P=0.034).
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