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Abstract: PO2631

Ferric Pyrophosphate Citrate Injection: No Clinical Drug Interaction with Unfractionated Heparin in Hemodialysis Patients

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Author

  • Pratt, Raymond D., Rockwell Medical Inc, Wixom, Michigan, United States
Background

Ferric pyrophosphate citrate (FPC) is a unique iron (Fe) replacement product indicated to maintain Fe balance and hemoglobin (Hgb) concentration in adult hemodialysis patients (HD). FPC can be administered via the dialysate (D) or as an intravenous (IV) preparation (Triferic® AVNU injection 6.75 mg Fe/4.5 mL for IV administration). A clinical study of the effects of unfractionated heparin (UFH) mixed with FPC was conducted.

Methods

An open-label, randomized 3-period, crossover trial, investigated the effects of FPC mixed with UFH compared with delivery of UFH and FPC by separate routes in 12 HD patients. The primary endpoint was the Anti Xa activity of UFH + FPC compared to UFH alone and UFH and FPC administered IV separately. Secondary endpoints were the activated prothrombin time (aPTT), thrombin time (TT) and serum iron profile (sFe). Effects were analyzed using the bioequivalence parameter of area under the concentration-time curve (AUC0-t). Safety was assessed by recording adverse events (AE) and a visual dialyzer clotting scale (VCS).

Results

Coadministration of FPC+UFH pre dialyzer, met bioequivalence criteria for anti Xa activity of UFH compared to UFH alone or UFH and FPC separately. [Figure 1]. The FPC +UFH mixture had no impact on the AUC0-t values of PTT or TT. The concentration-time profiles for sFe and TSAT were comparable.
FPC was well tolerated with no reported adverse events. The VCS showed no detectable clotting of the dialyzer with any combination of UFH and FPC.

Conclusion

The results of this study demonstrates no clinically significant drug-drug interaction between FPC and UFH on the anticoagulation effect as assessed by anti Xa activity, aPTT, and TT or on the ability of FPC to deliver iron when these agents are co-administered as a single admixture. All treatments were well tolerated. These results support coadministration of IV FPC and UFH as an admixture to HD patients.

Figure 1.: Anti Xa Activity

Funding

  • Commercial Support