title: Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis.
abstract: OBJECTIVE
  Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation).
  
  
  METHODS
  The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians' discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495.
  
  
  RESULTS
  The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9±1.2 and 10.96±1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar.
  
  
  CONCLUSIONS
  The epoetin formulations tested in this study are equivalent in efficacy and safety.
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Paulo D
authors.initials: PD
authors.lastname: Picon
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Suzane Cristina M
authors.initials: SC
authors.lastname: Pribbernow
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Prompt
authors.affiliation: Centro de Diálise e Transplantes de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Suzana C
authors.initials: SC
authors.lastname: Schacher
authors.affiliation: Centro de Diálise e Transplantes de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Veronica V H
authors.initials: VV
authors.lastname: Antunes
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Bianca P
authors.initials: BP
authors.lastname: Mentz
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Fabiane L
authors.initials: FL
authors.lastname: Oliveira
authors.affiliation: Centro de Diálise e Transplantes de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Celia Mariana B de
authors.initials: CM
authors.lastname: Souza
authors.affiliation: Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.
authors.forename: Fernando C
authors.initials: FC
authors.lastname: Schacher
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007501:Iron / Q000097:blood / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; D007501:Iron