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Kidney Week

Abstract: PO0489

Triferic (Ferric Pyrophosphate Citrate, FPC) Maintains Hemoglobin and Reduces Total IV Iron Requirement: Results from a Mid-Sized Dialysis Organization (MDO) Pilot Observational Analysis

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Shull, Samuel Lee, Rockwell Medical Inc, Wixom, Michigan, United States
  • Hoffman, Marc L., Rockwell Medical Inc, Wixom, Michigan, United States
Background

Triferic is approved as an iron (Fe) replacement product to maintain hemoglobin (Hb) in adult patients (pts) receiving chronic hemodialysis (HD).Randomized clinical trial data have demonstrated that FPC maintains Fe stores and Hb while reducing IV Fe usage with a safety profile similar to placebo. We now report the first 8 mos of an independent MDO’s experience using FPC for all HD patients (pts) during a pilot implementation at 14 clinics.

Methods

FPC was added to centrally delivered liquid bicarb to provide 110 µg Fe/L dialysate. All patients received FPC at each HD. Anonymized prospective data were provided between Sep 2020—Apr 2021. Clinics added FPC into their anemia mgmt. practices per existing protocols and standards of care (SoC). Supplemental IV Fe, up to a max of 1000 mg Fe/mth, was administered according to a protocol based on serum ferritin and TSAT values. At baseline, the ave. utilization of IV Fe was 197 mg/pt/mo. During the first 3 mos of FPC, clinics saw a modest 23% reduction of IV Fe (151mg/pt/mo)). A new Fe mgmt. protocol was released specifically designed to guide IV Fe use in conjunction with FPC; this was adopted by 9 clinics while 5 clinics chose to maintain their SoC.

Results

Within 3 mos of initiation of the new protocol, Fe utilization in this group decreased by 81%, conversely Fe utilization increased by 19% in the SoC group.During this period, Hb remained stable in both groups (+/- 0.2 g/dL from baseline). Concurrent with these changes Mircera® (-epoetin beta) dose remained stable in the SoC group but was reduced 37% (from post-adoption baseline) in the new group.

Conclusion

Additional clinics continued to adopt the new protocol over time. Taking into account the staggered adoption of the protocol, after 8 mos, the aggregate Fe utilization across all 14 clinics was reduced by 51% and trending lower. Mircera dose was stable (decreased 5%) and Hb remains stable. This observational study demonstrates that FPC is a well tolerated replacement for IV Fe when administered to all patients in a HD unit. The findings of this real-world observational study align with pivotal clinical trials and previously reported real-world evidence in terms of reduction of IV Fe use and maintenance of Hb.

Funding

  • Commercial Support