Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial

Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Nephrology Dialysis Transplantation Oxford University Press (OUP): Policy B

DOI: 10.1093/ndt/gfw264

Abstract

The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration.FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period.The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level >=800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin >=800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups.These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.

Authors with CRIS profile

Kai-Uwe Eckardt Department of Medicine 4 – Nephrology and Hypertension

Involved external institutions

King's College Hospital (KCH) GB United Kingdom (GB) Vifor Pharma AG CH Switzerland (CH) DaVita Inc. US United States (USA) (US) Eurodial PT Portugal (PT) Kantonsspital Aarau AG CH Switzerland (CH) University of Groningen / Rijksuniversiteit Groningen NL Netherlands (NL)

How to cite

APA:

Roger, S.D., Gaillard, C.A., Bock, A.H., Carrera, F., Eckardt, K.-U., Van Wyck, D.B.,... Macdougall, I.C. (2017). Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrology Dialysis Transplantation. https://dx.doi.org/10.1093/ndt/gfw264

MLA:

Roger, Simon D., et al. "Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial." Nephrology Dialysis Transplantation (2017).

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