title: Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study.
abstract: BACKGROUND
  Currently available intravenous (IV) iron agents vary in indication, dosing regimens and safety profiles. Ferric carboxymaltose (FCM) is a stable, non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues. The objective of the present study was to evaluate the safety of FCM compared with standard medical care (SMC) in dialysis (HD) and non-dialysis-dependent (NDD) chronic kidney disease (CKD) patients.
  
  
  METHODS
  Adults 18-85 years of age with CKD were enrolled. NDD-CKD (n = 204) patients received an undiluted IV dose of FCM (15 mg/kg to a maximum of 1000 mg IV) and HD-CKD (n = 50) patients received an undiluted IV push of 200 mg ~30-60 min into the dialysis session. Subjects randomized to the SMC group (n = 259) received treatment determined by the investigator that could include oral iron, IV iron or no iron.
  
  
  RESULTS
  Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated. Incidences of treatment-emergent adverse events were similar between the groups: 30.3% (77 of 254) in the FCM group and 32.8% (85 of 259) in the SMC group. Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate. There were no clinically significant differences in laboratory or clinical chemistry values or vital signs between the groups. There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin (Hb) improvement, including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of >12 g/dL.
  
  
  CONCLUSIONS
  FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations.
authors.affiliation: New York Hospital Medical Center of Queens, Flushing, NY, USA. cxcharyt@nyp.org
authors.forename: Chaim
authors.initials: C
authors.lastname: Charytan
authors.forename: Marializa V
authors.initials: MV
authors.lastname: Bernardo
authors.forename: Todd A
authors.initials: TA
authors.lastname: Koch
authors.forename: Angelia
authors.initials: A
authors.lastname: Butcher
authors.forename: David
authors.initials: D
authors.lastname: Morris
authors.forename: David B
authors.initials: DB
authors.lastname: Bregman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage*; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D011379:Prognosis; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D055815:Young Adult
chemical_list: D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose; D007501:Iron