Multicenter non-interventional post-authorization safety study (NI-PASS) to monitor the incidence of relevant and expected rare adverse events including lack of efficacy among CKD patients receiving s.c. Binocrit® or Epoetin alfa HEXAL®

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Observational Study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EPOETIN ALFA
• Medical condition to be studied:
  Chronic kidney disease

  Nephrogenic anaemia

Population studied

• 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:
  2500

Study design details

• Main study objective:
  The primary objective of this study is to assess the incidence of relevant and expected rare Adverse Events (defined as Adverse Events of Special Interest) in response to Binocrit® or Epoetin alfa HEXAL® s.c. treatment in patients with CKD-induced anemia.
• Outcomes:
  The primary endpoint will be the incidence of Adverse Events (AEs) of Special Interest (including Pure Red Cell Aplasia and Lack of Efficacy). AEs of Special Interest are defined in the safety section of the protocol. Incidence of serious AEs, incidence of AEs, number of patients discontinuing the study prematurely and reasons for discontinuations, red blood hematology parameters over time (hemoglobin concentration, red blood cells (RBC), absolute and relative reticulocyte counts, hematocrit), number of patients receiving transfusions (whole blood and/or packed RBC), weekly epoetin dosage over time
• Data analysis plan:
  Due to the nature of the study, only descriptive statistical methods will be applied. AE incidences will be presented as percentages of patients with the corresponding exact 95% Clopper-Pearson confidence intervals, as well as incidence rates based on duration at risk.