title: Clinical evaluation of heme iron polypeptide: sustaining a response to rHuEPO in hemodialysis patients.
abstract: BACKGROUND
  Optimizing iron and recombinant human erythropoietin (rHuEPO) therapy is necessary to achieve target hemoglobin levels and minimize costs as the end-stage renal disease (ESRD) population expands. Oral iron products in patients with ESRD have been largely abandoned, and the safety of intravenous (IV) iron preparations has improved with the introduction of new-generation compounds that have little allergenicity. Recent work suggests oral heme iron may be an effective supplement for hemodialysis (HD) patients because it is absorbed by patients with high ferritin levels, has fewer side effects, and its absorption is stimulated by erythropoietin administration.
  
  
  METHODS
  We performed an open, 6-month, prospective evaluation of heme iron in HD patients who had been on maintenance IV iron therapy. IV iron was discontinued and replaced with oral heme iron. Serum iron level, hematocrit (Hct), and erythropoietin and IV iron dose were monitored.
  
  
  RESULTS
  During 6 months, 4 of 37 patients (11%) dropped out because of insufficient iron supplementation or intolerance and 5 patients (14%) were dropped because of unrelated complications or protocol violation. A slight reduction in average transferrin saturation (TSAT) was seen early, but reversed, and no significant changes were seen in TSAT or Hct. A significant reduction in average serum ferritin level was seen at months 4 through 6 (P < 0.01).
  
  
  CONCLUSIONS
  During the 6-month study period, heme iron polypeptide successfully replaced IV iron therapy in a majority of HD patients and maintained target Hcts with no concomitant use of IV iron. This treatment was associated with a significant increase in rHuEPO efficiency (P = 0.04).
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Allen R
authors.initials: AR
authors.lastname: Nissenson
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Berns
authors.forename: Paul
authors.initials: P
authors.lastname: Sakiewicz
authors.forename: Sana
authors.initials: S
authors.lastname: Ghaddar
authors.forename: Gary M
authors.initials: GM
authors.lastname: Moore
authors.forename: Rhoda B
authors.initials: RB
authors.lastname: Schleicher
authors.forename: Paul A
authors.initials: PA
authors.lastname: Seligman
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005293:Ferritins / Q000097:blood; D006400:Hematocrit; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage / Q000097:blood; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins; D006435:Renal Dialysis; D013607:Tablets; D014168:Transferrin / Q000032:analysis; D016896:Treatment Outcome
chemical_list: D010455:Peptides; D011994:Recombinant Proteins; D013607:Tablets; D014168:Transferrin; D004921:Erythropoietin; D005293:Ferritins; D007501:Iron