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). Baseline ESA dose was similar between SFP (9448 U/wk) and placebo (9049 U/wk). In the modified ITT population, at the end of the study, ESA dose in the SFP arm was 10557 U/wk and placebo was 13345 U/wk. After adjusting for differences in baseline hemoglobin, the SFP arm required 37.1% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.034). The ESA sparing effect from SFP was observed without an increase in serum ferritin or transferrin saturation. A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.
Dr. Raymond Pratt, Chief Medical Officer of Rockwell Medical stated, "We are very excited about the results of this well-run study. The 11 microgram/dL SFP dose delivered sufficient iron without increasing iron stores while greatly reducing ESA dose. The safety profile of SFP was similar to placebo and was well tolerated. In this study, a 37% higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period. The PRIME results support our belief that SFP will demonstrate efficacy in the Phase 3 CRUISE clinical studies by maintaining hemoglobin in the SFP arm while hemoglobin decreases in the placebo arm."