LAUSR

Ferric pyrophosphate citrate (FPC) is indicated to maintain hemoglobin in chronic hemodialysis patients (CKD-5HD) by addition to the dialysate. An intravenous (IV) FPC presentation containing 6.75 mg iron in 4.5 mL was developed. The objective was to establish the equivalence of iron delivery via dialysate and IV infusion using a pharmacokinetic approach. An open-label, randomized, multiple period, single dose, crossover study was conducted in 27 CKD-5HD patients. Each patient received: 1) a basal iron profile over 12 hours; 2) FPC 6.75 mg Fe IV pre-dialyzer (Pre-D); 3) FPC 6.75 mg Fe IV post-dialyzer (Post-D) and 4) FPC 2 μM (110 μg Fe/L of hemodialysate (Fe-HD). Serum and plasma iron was analyzed for total Fe (sFetot and pFetot ) and Transferrin Bound Iron (TBI). Equivalence was determined by comparing Cmax and AUC0-last of Fe-HD (reference) and test treatments Fe Pre-D and Post-D iron profiles. The main outcome measure was the measurement of bioequivalence between the reference and test treatments. Bioequivalence parameters showed that infusion of FPC iron IV, pre- and post-dialyzer delivered equivalent iron as via hemodialysate. The increment in sFe from pre-dialysis to post-dialysis was the same as observed in the long-term clinical studies of FPC. FPC IV was well tolerated. Intravenous infusion of 6.75 mg iron as FPC during 3 hours of HD delivers an equivalent amount of iron as when Triferic is delivered via hemodialysate. The intravenous presentation of FPC extends the ability to provide FPC iron to all patients receiving hemodialysis or hemodiafiltration. This article is protected by copyright. All rights reserved.