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


METHODS
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.


RESULTS
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.


CONCLUSIONS
These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.
Renal Research, Gosford, NSW, Australia.
Simon D
SD
Roger
Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Carlo A
CA
Gaillard
Department of Nephrology, Kantonsspital, Aarau, Switzerland.
Andreas H
AH
Bock
Department of Dialysis, Eurodial, DaVita, Leiria, Portugal.
Fernando
F
Carrera
Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany.
Kai-Uwe
KU
Eckardt
Clinical Support Services, Davita Healthcare Partners, Denver, CO, USA.
David B
DB
Van Wyck
Vifor Pharma Ltd, Glattbrugg, Switzerland.
Maureen
M
Cronin
Vifor Pharma Ltd, Glattbrugg, Switzerland.
Yvonne
Y
Meier
Vifor Pharma Ltd, Glattbrugg, Switzerland.
Sylvain
S
Larroque
Department of Renal Medicine, King's College Hospital, London, UK.
Iain C
IC
Macdougall
D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005919:Glomerular Filtration Rate; D006801:Humans; D007501:Iron / Q000008:administration & dosage*; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D013997:Time Factors
D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose; D007501:Iron
anemia; cardiovascular disease; oxidative stress