Ferric Pyrophosphate Citrate: A Novel Iron Replacement Agent in Patients Undergoing Hemodialysis

Abstract

Management of anemia remains an integral component in the care of patients with chronic kidney disease undergoing hemodialysis. In addition to erythropoiesis-stimulating agents, iron-replacement agents remain a key strategy for anemia treatment in this patient population. Ferric pyrophosphate citrate (FPC), a novel iron-replacement agent, was approved by the US Food and Drug Administration in January 2015 for use in adult patients receiving chronic hemodialysis (HD). This iron product is administered to patients on HD via the dialysate. The recently published, multicenter, randomized, placebo-controlled, phase 3 clinical trials found FPC to maintain hemoglobin level and iron balance in patients undergoing chronic HD. The mean hemoglobin level in these phase 3 clinical studies was maintained from baseline to the end of the treatment in the dialysate iron (FPC-treated) group, however, it decreased by 0.4 g/dL in the control group (P < 0.001). Adverse and serious adverse events were similar in both groups. Another recent study showed a significant reduction in the prescribed ESA dose at the end of treatment in the FPC-treated group compared with placebo. These studies have shown that FPC administered via the dialysate is efficacious and apparently well tolerated. In this article, in addition to reviewing the clinical studies evaluating the efficacy and safety of FPC, we propose a protocol for iron management in HD centers where FPC is to be used.