title: Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.
abstract: BACKGROUND
  Although an erythropoiesis-stimulating agent (ESA) is most frequently administered intravenously for treatment of anemia in patients with chronic kidney disease who are on dialysis, few studies have compared the efficacy of different intravenous (i.v.) dosing schedules.
  
  
  METHODS
  This multicenter, phase IIIb, open-label, controlled study randomized 289 stable hemodialysis patients to continue with conventional dosing of i.v. epoetin alfa or darbepoetin, or to switch to once-weekly i.v. epoetin alfa at the same cumulative weekly starting dose, to maintain hemoglobin levels at 11.0-13.0 g/dL, and within 1.0 g/dL of the baseline value. Hemoglobin levels and ESA doses were recorded every 4 weeks for 28 weeks.
  
  
  RESULTS
  Hemoglobin levels fell significantly and ESA doses increased significantly between baseline and week 28 (mean of week 16-28 values) in the once-weekly epoetin alfa group, compared with the conventional treatment group (p< 0.001). The adjusted difference in mean hemoglobin levels between the groups was 0.73 g/dL (greater than the threshold for therapeutic equivalence of 0.5 g/dL). The changes between groups from baseline was significant at all time points for hemoglobin levels (0.36, 0.46, 0.81, 0.87, 0.78, 0.62 and 0.49 g/dL) and from week 12 for ESA dose (718.5, 1,326.5, 1,732.0, 1,839.7 and 1,959.1 IU/week; p=0.005). Hemoglobin was maintained at the target level in 78% and 84% of patients on conventional dosing, and 67% and 64% of those on once-weekly epoetin alfa in the intention-to-treat (p=0.1) and per protocol (p=0.016) populations, respectively.
  
  
  CONCLUSIONS
  This study did not show therapeutic equivalence of once-weekly i.v. epoetin alfa with conventional dosing regimens.
authors.affiliation: Division of Nephrology and Dialysis, A. Manzoni Hospital, Via Dell'Eremo 9, Lecco, Italy. nefrologia@ospedale.lecco.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Villa
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.forename: Armando
authors.initials: A
authors.lastname: Filippini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cannella
authors.forename: Giacomo
authors.initials: G
authors.lastname: De Ferrari
authors.forename: Agostino
authors.initials: A
authors.lastname: Naso
authors.forename: Egidio
authors.initials: E
authors.lastname: Rossi
authors.forename: Marco
authors.initials: M
authors.lastname: Formica
authors.forename: Luigi
authors.initials: L
authors.lastname: Lombardi
authors.forename: Ugo
authors.initials: U
authors.lastname: Rotolo
authors.forename: Feruccio
authors.initials: F
authors.lastname: Conte
mesh_terms: D000368:Aged; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa