Non-interventional Post Authorization Safety Study (PASS) to evaluate hypersensitivity reactions associated with administration of intravenous iron sucrose in Chronic Kidney Disease (CKD) patients, under dialysis or not

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:
  Intensive monitoring schemes, Active surveillance

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  IRON SUCROSE

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:
  570

Study design details

• Main study objective:
  The primary objective is to assess the proportion of hypersensitivity reactions after administration of IV iron sucrose in CKD patients, under dialysis or not as per standard clinical practice.
• Data analysis plan:
  The primary safety analysis will examine the frequency and percentage of patients experiencing hypersensitivity reactions, serious adverse events and adverse events associated with IV iron sucrose treatment. The adverse events will be coded using MedDRA (Medical Dictionary for Regulatory Activities) and tabulated by seriousness, system organ class and preferred term. The adverse event rates will be computed for all study patients combined as well as for subgroups of patients of particular interest.