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

Macdougall, IC; Bock, AH; Carrera, F; Eckardt, K-U; Gaillard, C; Van Wyck, D; Meier, Y; Larroque, S; Roger, SD; FIND-CKD Study investigators (2017) Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol, 18 (1). p. 24. ISSN 1471-2369 https://doi.org/10.1186/s12882-017-0444-6
SGUL Authors: Banerjee, Debasish

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Abstract

BACKGROUND: Preclinical studies demonstrate renal proximal tubular injury after administration of some intravenous iron 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-dialysis dependent chronic kidney disease (ND-CKD), anemia and iron deficiency without erythropoiesis-stimulating agent therapy 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 were 35.6 (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 from baseline 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. No significant association was detected between quartiles of FCM dose, change in ferritin or change in TSAT versus change in eGFR. Dialysis initiation was similar between groups. Renal adverse events were rare, with no indication of between-group differences. CONCLUSION: Intravenous FCM at doses that maintained ferritin levels of 100-200 μg/L or 400-600 μg/L did not negatively impact renal function (eGFR) in patients with ND-CKD over 12 months versus oral iron, and eGFR remained stable. These findings show no evidence of renal toxicity following intravenous FCM over a 1-year period. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT00994318 (first registration 12 October 2009).

Item Type: Article
Additional Information: © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Chronic kidney disease, Ferinject, Ferric carboxymaltose, Intravenous, Renal function, eGFR, Administration, Intravenous, Administration, Oral, Aged, Aged, 80 and over, Anemia, Iron-Deficiency, Disease Progression, Female, Ferric Compounds, Ferritins, Glomerular Filtration Rate, Humans, Iron, Kidney Failure, Chronic, Male, Maltose, Middle Aged, Renal Dialysis, Renal Insufficiency, Chronic, Severity of Illness Index, Trace Elements, Urology & Nephrology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: BMC Nephrol
ISSN: 1471-2369
Language: eng
Dates:
DateEvent
17 January 2017Published
10 January 2017Accepted
Publisher License: Creative Commons: Attribution 4.0
PubMed ID: 28095881
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110133
Publisher's version: https://doi.org/10.1186/s12882-017-0444-6

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