title: Safety and efficacy of total dose iron dextran administration in patients on home renal replacement therapies.
abstract: OBJECTIVE
  To determine the safety and efficacy of intravenous total dose iron (TDI) replacement in patients treated with home renal replacement therapy.
  
  
  METHODS
  Prospective open-label study on end points in the population studied.
  
  
  METHODS
  Institutional outpatient home dialysis program.
  
  
  METHODS
  The study included 20 end-stage renal disease (ESRD) patients, performing chronic peritoneal or home hemodialysis, with iron deficiency defined as ferritin < 100 ng/mL and/or an iron saturation < 20%.
  
  
  METHODS
  The total dose of iron dextran was calculated and infused at a rate not exceeding 6 mg/min. Hemoglobin, hematocrit, iron studies, and liver function tests (LFTs) were obtained before and 3 to 4 weeks after TDI infusion. Hematocrit of patients failing to achieve an increase in Hct over this period was re-examined 2 to 4 weeks later looking for a delayed response.
  
  
  METHODS
  Primary end points for efficacy were changes in Hct, ferritin, and iron saturation. Toxicity was measured as reported immediate and delayed symptoms and elevated transaminases and/or alkaline phosphatase levels.
  
  
  RESULTS
  A median iron dose of 1000 mg (range, 325-1500 mg) was administered. The infusions were generally well tolerated. Clinical adverse effects were seen in 2 patients weighing less than 50 kg. No increase in LFT results was seen. Hematocrit increased 2.2% (95% CI, 0.5%-3.9%) from 29.0% to 31.2% (p = 0.01) within 4 weeks of infusion. Significant increases also occurred in iron saturation (from 13% to 22%, p = 0.001) and ferritin (from 234 to 305 ng/mL, p = 0.008). Among the 9 patients who did not respond with a significant increase in Hct, 2 had a delayed response, increasing the overall response from 63% at 4 weeks to 71%, 8 weeks after TDI. Inadequate erythropoietin dosing and low-grade infectious/inflammatory disorders may have contributed to a poor response in several patients.
  
  
  CONCLUSIONS
  Total dose iron is a safe and effective means of restoring iron and erythropoietic response in ESRD patients weighing more than 50 kg who receive their renal replacement therapy at home.
authors.affiliation: Department of Medicine, Highland Hospital, University of Rochester School of Medicine and Dentistry, New York 14620, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Sloand
authors.forename: M A
authors.initials: MA
authors.lastname: Shelly
authors.forename: A L
authors.initials: AL
authors.lastname: Erenstone
authors.forename: M J
authors.initials: MJ
authors.lastname: Schiff
authors.forename: T E
authors.initials: TE
authors.lastname: Talley
authors.forename: M P
authors.initials: MP
authors.lastname: Dhakal
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006400:Hematocrit; D006437:Hemodialysis, Home; D006801:Humans; D007262:Infusions, Intravenous; D007505:Iron-Dextran Complex / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis; D011446:Prospective Studies
chemical_list: D006397:Hematinics; D007505:Iron-Dextran Complex