title: Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease.
abstract: Darbepoetin alfa, an erythropoiesis-stimulating glycoprotein, has proved efficacious in the treatment of anemia of chronic kidney disease (CKD) in adult subjects. However, little information is available from pediatric populations. We conducted an open-label, non-inferiority, 28-week study comparing the efficacy of darbepoetin alfa with that of recombinant human erythropoietin (rHuEpo) in pediatric subjects with CKD. Subjects, aged 1-18, who were receiving stable rHuEpo treatment (n=124) were randomized (1:2) to either continue receiving rHuEpo or convert to darbepoetin alfa, with doses titrated to achieve and maintain hemoglobin (Hb) levels between 10.0 and 12.5 g/dl. Darbepoetin alfa was considered to be non-inferior to rHuEpo if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change in Hb between the two treatment groups was above -1.0 g/dl. The adjusted mean change in Hb between the baseline and the evaluation period for the rHuEpo and darbepoetin alfa groups was -0.16 g/dl and 0.15 g/dl, respectively, with a difference of 0.31 g/dl (95% CI: -0.45, 1.07) between the means. These results, and the comparable safety profiles, demonstrate that darbepoetin alfa is non-inferior to rHuEpo in the treatment of anemia in pediatric patients with CKD.
authors.affiliation: The Children's Mercy Hospital, Kansas City, MO 64108, USA. bwarady@cmh.edu
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Warady
authors.forename: Mazen Y
authors.initials: MY
authors.lastname: Arar
authors.forename: Gary
authors.initials: G
authors.lastname: Lerner
authors.forename: Arline M
authors.initials: AM
authors.lastname: Nakanishi
authors.forename: Catherine
authors.initials: C
authors.lastname: Stehman-Breen
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology*; D002648:Child; D002908:Chronic Disease; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000150:complications*; D008297:Male
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa