title: Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients.
abstract: BACKGROUND
  Ferumoxytol is a unique intravenous (i.v.) iron therapy. This report examines factors affecting hemoglobin response to i.v. ferumoxytol, and the relationship between hematologic parameters, concomitant erythropoiesis-stimulating agents (ESA), and adverse events (AEs) in nondialysis CKD patients.
  
  
  METHODS
  A series of post-hoc efficacy and safety analyses were performed using pooled data from two identically designed Phase III studies in 608 nondialysis CKD patients randomized to receive two 510 mg i.v. injections of ferumoxytol within 5 ± 3 days versus oral iron.
  
  
  RESULTS
  Ferumoxytol resulted in a significant increase in hemoglobin in the presence and absence of ESA, and across a range of baseline hemoglobin, transferrin saturation, ferritin, and reticulocyte hemoglobin content levels. Adverse event rates with ferumoxytol were similar across quartiles of change in hemoglobin; there were no trends suggesting an increased rate of cardiovascular AEs with higher maximum achieved hemoglobin or faster rate of hemoglobin rise. There was no meaningful difference in the rate of AEs, serious AEs, and cardiovascular AEs between patients receiving or not receiving ESA.
  
  
  CONCLUSIONS
  These analyses add to the knowledge of predictors of response and safety outcomes associated with i.v. iron therapy in nondialysis CKD patients.
authors.affiliation: Hofstra North Shore LIJ, School of Medicine, Great Neck, NY 11021, USA. sfishbane@gmail.com
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.forename: W Kline
authors.initials: WK
authors.lastname: Bolton
authors.forename: Wolfgang C
authors.initials: WC
authors.lastname: Winkelmayer
authors.forename: William
authors.initials: W
authors.lastname: Strauss
authors.forename: Zhu
authors.initials: Z
authors.lastname: Li
authors.forename: Brian J G
authors.initials: BJ
authors.lastname: Pereira
mesh_terms: D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000097:blood* / Q000188:drug therapy* / Q000209:etiology; D002318:Cardiovascular Diseases / Q000139:chemically induced; D005260:Female; D005293:Ferritins / Q000097:blood; D052203:Ferrosoferric Oxide / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications; D012156:Reticulocytes / Q000378:metabolism; D014168:Transferrin / Q000378:metabolism
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D014168:Transferrin; D005293:Ferritins; D052203:Ferrosoferric Oxide