Post-authorization safety study with Epoetin theta in patients with chronic kidney disease An observational, non-interventional, multinational, multicentre, uncontrolled, prospective cohort study

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
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EPOETIN THETA
• Medical condition to be studied:
  Ischaemic stroke

  Myocardial infarction

  Cardiac failure

  Cardiac disorder

  Aplasia pure red cell

Population studied

• Short description of the study population:
  Chronic Kidney Disease (CKD) patients treated with Epoetin theta.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 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:
  1000

Study design details

• Main study objective:
  The primary objective of this PASS was to assess the incidence and severity of predefined cardiovascular events including ischaemic stroke in a large population of 1,000 CKD patients treated with Epoetin theta.
• Outcomes:
  Incidence and severity of predefined cardiovascular events, including ischaemic stroke, Any additional adverse drug reaction (ADR), including possible risk of PRCA.
• Data analysis plan:
  Due to the non-interventional character of this study, only an exploratory descriptive statistical analysis was performed.Qualitative (i.e. binary, categorical and ordinal) parameters were summarized by means of descriptive statistics, i.e. mean, standard deviation, median, minimum and maximum for continuous variables or frequency tables for categorical variables. The analysis of safety data was done separately for reportable adverse events (RAE, i.e. predefined cardiovascular events including ischaemic stroke) and for ADRs.RAEs were analyzed using the subterms summarised under the topics “cardiac disorders”, “cardiac failure”, “myocardial infarction”, and “ischaemic stroke”.The incidences of RAEs and ADRs were summarised by severity and frequency. Two-sided 95% Clopper-Pearson CIs were calculated, if appropriate.For patients with RAE, plots of the Hb values (including median and mean values) were provided.