A non-interventional study of Diafer® (5% Iron Isomaltoside 1000) administered according to standard hospital practice and product labelling in subjects with Chronic Kidney Disease on Haemodialysis for treatment of iron deficiency (Diafer-NIS-06)

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:
  Combined primary data collection and secondary use of data

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B03A) IRON PREPARATIONS

  IRON PREPARATIONS
• Medical condition to be studied:
  Haemodialysis

Population studied

• Short description of the study population:
  Patients ≥ 18 years of age and in a stable phase of chronic kidney disease (CKD), had been on haemodialysis (HD) therapy > 3 months, and had received at least one dose of iron sucrose (IS) treatment within the last 6 months before study start while being on HD.
• 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:
  200

Study design details

• Main study objective:
  The primary objective of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labelling in routine clinical practice in haemodialysis patients with chronic kidney disease.
• Outcomes:
  The primary efficacy outcome is haemoglobin concentration compared to baseline. Key secondary endpoints include iron dose, erythropoietin-stimulating agent dose, haematinics and safety.
• Data analysis plan:
  The data will be displayed by descriptive statistics and by comparing results from the patients to historical data from the same patients.