PRIME ESA sparing study has been completed and demonstrated a statistically significant 35% overall ESA reduction and by 74% in hypo-responders representing approximately 20% of ESRD population which typically use 2-3 times more ESA than normal dosing. Data released in February and May 2013.
The PRIME study data showed that regular administration of Triferic via dialysate over a 9-month period significantly reduced the amount of ESAs necessary for patients on hemodialysis compared to placebo.
The PRIME study was a multi-center, 103-patient, randomized controlled nine-month study with patients receiving either Triferic dialysate or standard (iron free) dialysate. IV iron sucrose (Venofer ®) can be dosed in either group per protocol in cases of iron deficiency. Clinical study design was aimed at demonstrating ESA sparing as well as examine maintenance of hemoglobin, iron parameters, the need for intravenous (IV) iron, and oxidative stress markers in patients receiving Triferic.
A 718-patient Phase III crossover safety study of Triferic in dialysate was completed January 2014. This clinical program is the largest and longest cohort of any parenteral iron drug with over 100,000 separate Triferic administrations.
These safety studies were the continuation of the Cruise efficacy trials and Study SFP-6, a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, Phase 3 study with an enrollment of 718 CKD-HD patients in the US and Canada. Both studies allowed patients to continue to receive Triferic in the open-label extensions study for up to one additional year. Consistent with expectations, a preliminary review of the safety data revealed: