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Abstract: PO2624

Continuous Low-Dose Iron Sucrose or Periodic High-Dose Ferric Carboxymaltose Therapy in Hemodialysis Patients (COPEFER): A Randomized Controlled Noninferiority Trial

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Bielesz, Bernhard O., Medizinische Universitat Wien Universitatsklinik fur Innere Medizin III, Wien, Wien, Austria
  • Lorenz, Matthias, Vienna Dialysis Center, Vienna, Austria, Wien, Wien, Austria
  • Monteforte, Rossella, Medizinische Universitat Wien Universitatsklinik fur Innere Medizin III, Wien, Wien, Austria
  • Prikoszovich, Thomas, Vienna Dialysis Center, Vienna, Austria, Wien, Wien, Austria
  • Gabriel, Michaela, Vienna Dialysis Center, Vienna, Austria, Wien, Wien, Austria
  • Wolzt, Michael, Section for Medical Statistics, and Department of Clinical Pharmacology, Medical University of Vienna, Austria, Wien, Wien, Austria
  • Gleiss, Andreas, Medizinische Universitat Wien, Wien, Wien, Austria
  • Sunder-Plassmann, Gere, Medizinische Universitat Wien Universitatsklinik fur Innere Medizin III, Wien, Wien, Austria
Background

Intravenous iron therapy is a cornerstone in the treatment of anemia in chronic hemodialysis patients. However, optimal dosing and frequency of administration is unknown and varies widely between centers. We compared the impact of equal cumulative doses of ferric carboxymaltose (FCM), which is not yet approved for use in hemodialysis patients, and iron sucrose (IS) administered as either a high dose bolus or low dose maintenance iron dosing strategy on hemoglobin concentration, iron balance, use of erythropoiesis stimulating agents (ESA), and adverse events in prevalent chronic hemodialysis patients.

Methods

We performed an open-label randomized controlled non-inferiority trial in two centers over 40 weeks (n=142). A total cumulative dose of two grams of iron was administered. The IS arm received 100 mg every two weeks, the FCM arm 500 mg every 10 weeks. Hemoglobin, iron markers, ESA use, C-reactive protein (CRP), phosphate, and liver enzymes were assessed. Primary end-point was the difference in hemoglobin at week 40 from baseline. A non-inferiority margin of -0.8 g/dl between both groups was pre-specified. Secondary end-points were differences in ferritin, transferrin saturation (TSAT), and ESA use.

Results

108 patients completed the study. By 40 weeks non-inferiority criterion was not met as hemoglobin differed by -0.47 g/dl (95% CI: -0.95 to 0.01) in the FCM compared to the IS arm. In intention-to-treat analysis hemoglobin was significantly lower in the FCM arm compared to the IS arm (-0.46 g/dl (95% CI -0.92 to -0.01). At week 40, ferritin was 29.7% (95% CI 6.6 to 46.1) and TSAT was 27.7% (95% CI 16.3 to 36.6) lower in the FCM compared to the IS arm. ESA dosing, CRP, phosphate, and liver function parameters did not differ between groups. Adverse events that caused intermittent drug discontinuations and infections occurred more often in the IS arm.

Conclusion

IS administered more frequently at lower doses maintained hemoglobin and iron stores more effectively than FCM administered less frequently but at higher doses. However, FCM appeared safe in dialysis patients where we observed less infections compared to the IS group.

Funding

  • Commercial Support