title: Darbepoetin alfa for the treatment of anemia in children undergoing peritoneal dialysis: a multicenter prospective study in Japan.
abstract: BACKGROUND
  Darbepoetin alfa (DA) is an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia. Since DA has not been approved by the appropriate Japanese drug regulatory agencies for the indication of renal anemia in children in Japan, we have conducted a multicenter prospective study to determine the efficacy and safety of DA in Japanese children undergoing peritoneal dialysis (PD).
  
  
  METHODS
  Pediatric patients subcutaneously receiving rHuEPO were switched to DA treatment for a period of 28 weeks. The conversion to the initial dose of DA was calculated as 1 μg DA for 200 IU rHuEPO, and DA was administered intravenously once every 2 weeks. The target hemoglobin (Hb) concentration was defined as 11.0 to ≤13.0 g/dL. In some patients, the dose of DA was adjusted appropriately to achieve this target level, and/or the dosing frequency changed to once every 4 weeks.
  
  
  RESULTS
  In the 25 patients switched from rHuEPO to DA the mean Hb concentration increased from 9.9 ± 1.0 to 11.1 ± 1.0 g/dL at 8 weeks following commencement of the DA treatment. The target Hb concentration was achieved in 88 % of these patients, and 60 % maintained this target value on completion of the study. The dosing frequency was extended to once every 4 weeks in 60 % of patients. Twenty-four adverse events were noted in 11 of 25 patients (44 %); however, there was no causality between DA and adverse events.
  
  
  CONCLUSIONS
  The results of this study suggest that intravenous administration of DA once every 2 or 4 weeks is an effective and safe treatment for renal anemia in Japanese children undergoing PD.
authors.affiliation: Department of Pediatric Nephrology, School of Medicine, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. hattori@kc.twmu.ac.jp
authors.forename: Motoshi
authors.initials: M
authors.lastname: Hattori
authors.forename: Akira
authors.initials: A
authors.lastname: Matsunaga
authors.forename: Yuko
authors.initials: Y
authors.lastname: Akioka
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Fujinaga
authors.forename: Takuhito
authors.initials: T
authors.lastname: Nagai
authors.forename: Osamu
authors.initials: O
authors.lastname: Uemura
authors.forename: Hyogo
authors.initials: H
authors.lastname: Nakakura
authors.forename: Akira
authors.initials: A
authors.lastname: Ashida
authors.forename: Koichi
authors.initials: K
authors.lastname: Kamei
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ito
authors.forename: Takuji
authors.initials: T
authors.lastname: Yamada
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Goto
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Ohta
authors.forename: Masataka
authors.initials: M
authors.lastname: Hisano
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Noritomo
authors.initials: N
authors.lastname: Itami
mesh_terms: D000293:Adolescent; D000740:Anemia / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy*; D008297:Male; D010530:Peritoneal Dialysis; D011446:Prospective Studies
chemical_list: D004921:Erythropoietin; D000068256:Darbepoetin alfa