VERIFIE (Velphoro Evaluation of Real-lIfe saFety, effectIveness and adherencE): Non-interventional study to investigate the short- and long-term real-life safety, effectiveness, and adherence of Velphoro in patients with hyperphosphataemia undergoing haemodialysis or peritoneal dialysis

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VELPHORO
• Medical condition to be studied:
  Hyperphosphataemia

Population studied

• Short description of the study population:
  Patients with hyperphosphataemia undergoing haemodialysis or peritoneal dialysis.
• Age groups:
  • 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:
  1400

Study design details

• Main study objective:
  The MAH wishes to obtain further systematic data within this non-interventional study to investigate short and long-term (beyond 1 year) safety, including GI effects, potential masking of GI bleedings due to stool discolouration, and the risk of iron accumulation. Evaluation of PD patients is of special interest, since their numbers have been limited within the clinical trials.
• Outcomes:
  • To evaluate short and long-term (beyond 1 year) safety and tolerability of Velphoro in general in HD and PD patients.• To specifically assess the potential risk of iron accumulation of Velphoro in HD and PD patients.• To investigate the potential masking of GI bleedings in patients treated with Velphoro in HD and PD patients. • To evaluate the effectiveness of Velphoro in routine clinical practice.• To evaluate the adherence to Velphoro therapy.
• Data analysis plan:
  Statistical analyses will be of an exploratory and descriptive nature. All variables will be analysed descriptively with appropriate statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by descriptive statistics (i.e. number of patients (n), mean, standard deviation, minimum, median, quartiles, and maximum). Continuous variables will be summarised by absolute value and changes from baseline per analysis time point, if applicable.All analyses will be performed for the total study population (overall analysis). In addition, data will be stratified by type of dialysis treatment (HD or PD respectively) and by duration of Velphoro treatment. Whenever reasonable and dependent on the number of patients in each specific subgroup, data will be stratified by further parameters.The sample size and disposition information by analysis time point will be displayed in a frequency table.