A Randomized Trial of the IMPACT of Ferric Citrate on Erythropoietin and Intravenous Iron Use in Patients Receiving Dialysis.

Abstract

Ferric citrate (FC) is an FDA-approved iron-based phosphate binder for adults with dialysis-dependent chronic kidney disease. This study investigated the impact of FC as the primary phosphate-lowering therapy on utilization of erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron. In this randomized, open-label, active-controlled, multicenter study (NCT04922645), patients on dialysis and receiving ESAs were randomized to receive FC or remain on standard of care (SOC) phosphate-lowering therapy for up to 6 months. Primary endpoints were the difference in change from baseline to efficacy evaluation period (EEP) in mean monthly ESA and IV iron doses. Secondary endpoints included treatment differences in hemoglobin, phosphate, TSAT, and ferritin levels. 209 patients were randomized to FC and had a Day 1 Dosing Visit (n=103) or SOC (n=106). The two groups had similar baseline laboratory characteristics, however atherosclerotic CV disease, peripheral vascular disease, and congestive heart failure were more common in the SOC group. The mean treatment difference in ESA monthly dose was -30.8 µg (FC vs SOC; p=0.02). An absolute though non-statistically significant change in mean monthly IV iron dose of -37.2 mg (p=0.17) was observed with FC. Mean hemoglobin, TSAT, and ferritin all increased from baseline to the EEP with FC vs. SOC. Serious adverse events occurred in 28% of patients receiving FC vs. 37% in those receiving SOC. In patients receiving dialysis, treatment with FC as compared to remaining on SOC phosphate binders resulted in reductions in mean monthly ESA and IV iron dose.