Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial

  1. Macdougall, Iain C.
  2. Martins Muñoz, Judith Fátima
  3. Bock, Andreas H.
  4. Carrera, Fernando
  5. Eckardt, Kai-Uwe
  6. Gaillard, Carlo
  7. Van Wyck, David
  8. Meier, Yvonne
  9. Larroque, Sylvain
  10. Roger, Simon D.
Revista:
BMC Nephrology

ISSN: 1471-2369

Año de publicación: 2017

Volumen: 18

Número: 1

Tipo: Artículo

DOI: 10.1186/S12882-017-0444-6 GOOGLE SCHOLAR lock_openAcceso abierto editor

Otras publicaciones en: BMC Nephrology

Resumen

Background: Preclinical studies demonstrate renal proximal tubular injury after administration of some intravenousiron preparations but clinical data on renal effects of intravenous iron are sparse.Methods: FIND-CKD was a 56-week, randomized, open-label, multicenter study in which patients with non-dialysisdependent chronic kidney disease (ND-CKD), anemia and iron deficiency without erythropoiesis-stimulating agenttherapy received intravenous ferric carboxymaltose (FCM), targeting either higher (400–600 μg/L) or lower (100–200 μg/L)ferritin values, or oral iron.Results: Mean (SD) eGFR at baseline was 34.9 (11.3), 32.8 (10.8) and 34.2 (12.3) mL/min/1.73 m2 in the high ferritin FCM(n = 97), low ferritin FCM (n = 89) and oral iron (n = 167) groups, respectively. Corresponding values at month 12 were35.6 (13.8), 32.1 (12.7) and 33.4 (14.5) mL/min/1.73 m2. The pre-specified endpoint of mean (SE) change in eGFR frombaseline to month 12 was +0.7 (0.9) mL/min/1.73 m2 with high ferritin FCM (p = 0.15 versus oral iron), -0.9(0.9) mL/min/1.73 m2 with low ferritin FCM (p = 0.99 versus oral iron) and -0.9 (0.7) mL/min/1.73 m2 with oral iron. Nosignificant association was detected between quartiles of FCM dose, change in ferritin or change in TSAT versus changein eGFR. Dialysis initiation was similar between groups. Renal adverse events were rare, with no indication ofbetween-group differences.Conclusion: Intravenous FCM at doses that maintained ferritin levels of 100–200 μg/L or 400–600 μg/L didnot negatively impact renal function (eGFR) in patients with ND-CKD over 12 months versus oral iron, andeGFR remained stable. These findings show no evidence of renal toxicity following intravenous FCM over a1-year period.

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Información de financiación

Financiadores

  • The FIND-CKD study was funded by Vifor Pharma, Glattbrugg, Switzerland. Medical writing supported was provided by a freelance medical writer funded by Vifor Pharma (C Dunstall).

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