FP654TRIFERIC HAS A SAFETY PROFILE SIMILAR TO PLACEBO: AN INTEGRATED SAFETY ANALYSIS OF PHASE 2 AND 3 STUDIES

Abstract

Background: Triferic is a novel soluble iron compound delivered via the dialysate to prevent iron deficiency and maintain hemoglobin in CKD‐HD patients. Methods: The Triferic clinical program included 3 large placebo‐controlled efficacy studies lasting 36 to 48 weeks (Controlled Studies), one large placebo‐controlled short‐term safety study, 3 open‐label (OL) safety studies of up to 48 weeks, and 3 small controlled early Phase 2 studies. Patients randomized to Triferic in the 2 pivotal controlled studies who completed the randomized treatment and transitioned to the OL study received Triferic for up to 72 weeks. Results: Exposure‐adjusted most frequent adverse event rates (AE) are presented in the table below. Discontinuations and exposure‐adjusted AE were similar to placebo in the controlled studies with no increase in the OL studies. The exposure‐adjusted mortality rate in the Controlled Triferic group was 7.9/100 PYE, compared to 7.2/100 PYE in placebo. The mortality rate in the All Triferic group was 6.5/100 PYE. No deaths occurred during Triferic administration and none were attributed to Triferic. There were no reports of anaphylaxis in over 100,000 individual doses of Triferic. Suspected hypersensitivity reactions, vascular access thrombotic events, composite cardiovascular events and systemic or serious infections were also similar between the Triferic and placebo groups. Conclusions: Triferic was well tolerated in long‐term controlled and OL studies. Triferic, administered at each treatment, maintained Hgb and iron balance compared to placebo. The safety profile in short and long‐term studies supports a favorable benefit‐risk profile for use as a maintenance iron therapy for CKD‐HD patients. (Table Presented).