title: Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial.
abstract: 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.
  
  
  
  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.
  
  
  
  Mean (SD) eGFR at baseline was 34.9 (11.3), 32.8 (10.8) and 34.2 (12.3) mL/min/1.73 m2in 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 m2with high ferritin FCM (p = 0.15 versus oral iron), -0.9 (0.9) mL/min/1.73 m2with low ferritin FCM (p = 0.99 versus oral iron) and -0.9 (0.7) mL/min/1.73 m2with 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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov NCT00994318 (first registration 12 October 2009).
authors.affiliation: Department of Renal Medicine, King's College Hospital, Denmark Hill, London, SE5 9RS, UK. iain.macdougall@nhs.net.
authors.forename: Iain C
authors.initials: IC
authors.lastname: Macdougall
authors.affiliation: Department of Nephrology, Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Andreas H
authors.initials: AH
authors.lastname: Bock
authors.affiliation: Eurodial, DaVita, Leiria, Portugal.
authors.forename: Fernando
authors.initials: F
authors.lastname: Carrera
authors.affiliation: Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany.
authors.forename: Kai-Uwe
authors.initials: KU
authors.lastname: Eckardt
authors.affiliation: Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Carlo
authors.initials: C
authors.lastname: Gaillard
authors.affiliation: DaVita Healthcare Partners Inc., Denver, CO, USA.
authors.forename: David
authors.initials: D
authors.lastname: Van Wyck
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Meier
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Larroque
authors.affiliation: Renal Research, Gosford, NSW, Australia.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000150:complications / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D005293:Ferritins / Q000378:metabolism; D005919:Glomerular Filtration Rate; D006801:Humans; D007501:Iron / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000453:epidemiology / Q000628:therapy; D008297:Male; D008320:Maltose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000378:metabolism*; D012720:Severity of Illness Index; D014131:Trace Elements / Q000627:therapeutic use*
chemical_list: D005290:Ferric Compounds; D014131:Trace Elements; C522335:ferric carboxymaltose; D008320:Maltose; D005293:Ferritins; D007501:Iron
keywords: Chronic kidney disease; Ferinject; Ferric carboxymaltose; Intravenous; Renal function; eGFR