Thromboembolic Risk in Patients with Chronic Kidney Disease Treated receiving Epoetin zeta or other Erythropoietin Stimulating Agents – the BIPS 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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Nested case-control study

Study drug and medical condition

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

  erythropoietin

  (B03XA02) darbepoetin alfa

  darbepoetin alfa

  (B03XA03) methoxy polyethylene glycol-epoetin beta

  methoxy polyethylene glycol-epoetin beta
• Medical condition to be studied:
  Chronic kidney disease

Population studied

• Short description of the study population:
  Patients with chronic kidney disease (CKD) included in the GePaRD exposed for the first time to epoetin zeta, epoetin alfa or other epoetins available on the market during the study period.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  5200

Study design details

• Main study objective:
  The primary objective of this study is to compare the incidence of thromboembolic events in patients with renal anaemia treated with epoetin zeta and patients with renal anaemia treated with epoetin alpha.
• Outcomes:
  The main study endpoint is the composite endpoint of the three thromboembolic events:• Acute myocardial infarction• Deep vein thrombosis and/or pulmonary embolism• Cerebrovascular event i.e. cerebrovascular accident, cerebral infarction, transient ischaemic attack or cerebral haemorrhage. These three events will be analysed separately as secondary outcomes.
• Data analysis plan:
  The risk of thromboembolic events in CKD patients treated with epoetin zeta will be compared to the risk of thromboembolic events in CKD patients treated with epoetin alpha or other epoetins in a case-control analysis. Epoetin users will be identified based on drug prescriptions. Risk assessment in all groups of patients during the study period will be based on hospital or outpatient diagnoses. Information on sex, year of birth, SHI, co-morbidity, and co-medication will be gathered for the study period and for the year before cohort entry. Cases will be defined as current users if they are exposed to any ESA on the index day, as recent users if ESA exposure ends 1-30 days before the index day, and as past users if ESA exposure ends > 30 days before the index day.