title: FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia.
abstract: BACKGROUND
  The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown.
  
  
  METHODS
  Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L) ferritin or oral iron therapy. The primary end point was time to initiation of other anaemia management (ESA, other iron therapy or blood transfusion) or haemoglobin (Hb) trigger of two consecutive values <10 g/dL during Weeks 8-52.
  
  
  RESULTS
  The primary end point occurred in 36 patients (23.5%), 49 patients (32.2%) and 98 patients (31.8%) in the high-ferritin FCM, low-ferritin FCM and oral iron groups, respectively [hazard ratio (HR): 0.65; 95% confidence interval (CI): 0.44-0.95; P = 0.026 for high-ferritin FCM versus oral iron]. The increase in Hb was greater with high-ferritin FCM versus oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase ≥1 g/dL with high-ferritin FCM versus oral iron (HR: 2.04; 95% CI: 1.52-2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups.
  
  
  CONCLUSIONS
  Compared with oral iron, IV FCM targeting a ferritin of 400-600 µg/L quickly reached and maintained Hb level, and delayed and/or reduced the need for other anaemia management including ESAs. Within the limitations of this trial, no renal toxicity was observed, with no difference in cardiovascular or infectious events.
  NCT00994318.
authors.affiliation: Department of Renal Medicine, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
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 Centre 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: Bernard
authors.initials: B
authors.lastname: Roubert
authors.affiliation: Vifor Pharma, Glattbrugg, Switzerland.
authors.forename: Jacqueline G
authors.initials: JG
authors.lastname: Nolen
authors.affiliation: Renal Research, Gosford, NSW, Australia.
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
mesh_terms: D000284:Administration, Oral; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005293:Ferritins / Q000097:blood*; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage*; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D006454:Hemoglobins; C522335:ferric carboxymaltose; D008320:Maltose; D005293:Ferritins; D007501:Iron
keywords: anaemia; chronic kidney disease