title: Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial.
abstract: BACKGROUND
  Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease (ND-CKD) but it is unclear if oral supplementation is as effective as intravenous (IV) supplementation in re-establishing iron stores. The purpose of this study was to determine if oral Heme Iron Polypeptide (HIP) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD.
  
  
  METHODS
  Forty ND-CKD patients were randomized; 18 to HIP 11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months. Baseline clinical and laboratory data were collected for all patients. The primary and secondary outcomes for the study were hemoglobin (Hgb) concentration and iron indices [ferritin and percentage transferrin saturation (TSAT)] at the end of 6 months respectively. Adverse events were also compared.
  
  
  RESULTS
  The baseline demographic characteristics and laboratory values were similar for the two groups. After 6 months of treatment, Hb in the HIP group was 117 g/L and 113 g/L in the IV sucrose group (p = 0.37). The TSAT at 6 months was not different between the two groups {p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group {85.5 ug/L in HIP and 244 ug/L; p = 0.004}. Overall adverse events were not different between the groups.
  
  
  CONCLUSIONS
  HIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months. It is unclear if the greater ferritin values in the IV iron sucrose group are clinically significant.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00318812.
authors.affiliation: Department of Nephrology, Kasturba Medical College, Manipal, Karnataka,India.
authors.forename: Shankar P
authors.initials: SP
authors.lastname: Nagaraju
authors.forename: Adam
authors.initials: A
authors.lastname: Cohn
authors.forename: Ayub
authors.initials: A
authors.lastname: Akbari
authors.forename: Janet L
authors.initials: JL
authors.lastname: Davis
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Zimmerman
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D003956:Dialysis; D005260:Female; D006801:Humans; D007501:Iron / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage*; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D010455:Peptides; D007501:Iron