Ferric Citrate Dosing in Iron Deficiency Anemia in Nondialysis-Dependent Chronic Kidney Disease

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Pablo E Pergola1, Diogo Belo2, Paul Crawford3

  • 1Renal Associates PA, San Antonio, Texas, USA.

American Journal of Nephrology
|July 22, 2021
PubMed

Insights

Ferric citrate (FC) effectively treats anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Both twice-daily and three-times-daily dosing regimens demonstrated safety and efficacy over 48 weeks.

Area of Science:

  • Nephrology
  • Hematology
  • Pharmacology

Background:

  • Iron deficiency anemia is common in nondialysis-dependent chronic kidney disease (NDD-CKD).
  • Ferric citrate (FC) is an oral iron replacement therapy for anemia in NDD-CKD.
  • Standard FC dosing is 1g three times daily (TID).

Purpose of the Study:

  • To investigate the long-term efficacy and safety of different ferric citrate (FC) dosing regimens.
  • To compare FC administered three times daily (TID) versus twice daily (BID) in NDD-CKD patients.
  • To assess the impact of varied FC dosing on hemoglobin levels.

Main Methods:

  • Phase 4, randomized, open-label, multicenter study.
  • 206 NDD-CKD patients with anemia were randomized to FC 3g/day TID or 4g/day BID.
  • Dose adjustments were made at week 12 based on hemoglobin response.

Main Results:

  • Mean change in hemoglobin (Hb) from baseline to week 24 was 0.77 g/dL for FC TID and 0.70 g/dL for FC BID.
  • Both dosing regimens showed comparable efficacy in increasing Hb levels.
  • No significant safety concerns were reported for either dosing regimen.

Conclusions:

  • Ferric citrate (FC) administered BID and TID for 48 weeks is safe and effective for treating anemia in NDD-CKD.
  • The study supports increased dosing flexibility for FC in this patient population.
  • Further research may explore optimal individualized dosing strategies.
Abstract

Keywords:
Chronic kidney diseaseDosing flexibilityFerric citrateIron deficiency anemia

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