Observational, non-interventional, multicenter study of adverse events in hemodialysis patients receiving ESA (erythropoiesis-stimulating agents) originators or biosimilars (ESAVIEW -View on erythropoiesis-stimulating agents)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B03XA01) erythropoietin

  erythropoietin

  (B03XA02) darbepoetin alfa

  darbepoetin alfa
• Medical condition to be studied:
  Dialysis

Population studied

• Short description of the study population:
  All adult (≥ 18 years) chronic kidney disease (CKD) outpatients undergoing hemodialysis at least twice a week and who were treated with epoetins as per the clinical practice of the participating hospitals. The study population comprised both prevalent users (patients already on ESAs before inclusion in the study) and incident users (patients starting the use of ESA at inclusion).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  The main objective is the safety profile of ESAs: originators and biosimilars. The secondary objectives are the effectiveness and the cost-effectiveness of ESA (originators and biosimilars).
• Outcomes:
  Adverse events to ESAs (originators vs biosimilars), Utilization and effectiveness of ESAs (originators vs biosimilars)
• Data analysis plan:
  For each variable and for each endpoint a statistic description with a confidence intervals at 95% will be produced. The primary endpoint will be synthesized by specific indicators such as the cumulative incidence in each cohort, the incidence rate and the incidence patients. The stratification will be based on appropriate indicators such as: the time of exposure to erythropoietin prior to the start of the study, the time passed since the first dialysis and the number of changes of erythropoietin. For each exposure the incidence rate will also be calculated. Categorical variables will be analyzed using univariate (the Chi square test and Fisher's exact test) or multivariate analysis (logistic regression) . Continuous variables will be analyzed using parametric (eg, t-tests, ANOVA) or non-parametric (eg, Mann-Witney test) analysis. The variables "time to failure" will be analyzed by Kaplan Meier method or Cox regression. All tests will be carried out in two tails.