title: Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients.
abstract: OBJECTIVE
  The doses of darbepoetin alfa required to maintain target haemoglobin levels after s.c. or i.v. administration when recombinant human erythropoietin (rHuEpo) treatment was replaced by darbepoetin alfa treatment in haemodialysis (HD) patients were compared.
  
  
  METHODS
  In this prospective, randomized, open-label study, 65 HD patients who were receiving stable SC doses of rHuEpo were switched to an equivalent dose of darbepoetin alfa at a reduced frequency by s.c. or i.v. administration. Patients were randomly assigned to the s.c. group (n = 32) or the i.v. group (n = 33). Darbepoetin alfa doses were titrated to maintain target haemoglobin levels of 8.0-11.0 g/dL for up to 24 weeks. A period of 20 weeks was used for dose titration and haemoglobin stabilization. This was followed by a 4 week evaluation period.
  
  
  RESULTS
  The mean haemoglobin concentration during the evaluation period was similar in the s.c. and i.v. groups. The mean dose and mean weight-standardized dose of darbepoetin alfa during the evaluation period tended to be lower in the s.c. group than the i.v. group, although these differences were not statistically significant. The mean weekly darbepoetin alfa dose requirements during the evaluation period significantly decreased in both groups compared to the dose requirements at randomization.
  
  
  CONCLUSIONS
  There is a possibility that s.c. administration of darbepoetin alfa is more efficacious than i.v. administration, but a definite benefit cannot be demonstrated with the current sample size. A bigger sample size is needed to confirm the result.
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
authors.forename: Chan-Duck
authors.initials: CD
authors.lastname: Kim
authors.forename: Sun-Hee
authors.initials: SH
authors.lastname: Park
authors.forename: Dae-Joong
authors.initials: DJ
authors.lastname: Kim
authors.forename: Jong-Won
authors.initials: JW
authors.lastname: Park
authors.forename: Jun-Young
authors.initials: JY
authors.lastname: Do
authors.forename: Suk-Kyun
authors.initials: SK
authors.lastname: Shin
authors.forename: Beom-Seok
authors.initials: BS
authors.lastname: Kim
authors.forename: Jung-Ju
authors.initials: JJ
authors.lastname: Seo
authors.forename: Yong-Lim
authors.initials: YL
authors.lastname: Kim
mesh_terms: D000740:Anemia / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D011446:Prospective Studies; D006435:Renal Dialysis
chemical_list: D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa