An observational post-authorisation safety study (PASS) in Europe to further characterise and quantify long-term safety profile with respect to neurotoxicity, chronic nephrotoxicity, and malignancy with use of voclosporin

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LUPKYNIS
• Study drug International non-proprietary name (INN) or common name:
  VOCLOSPORIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AD03) voclosporin

  voclosporin

Population studied

• Age groups:
  Adult and elderly population (≥18 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Lupus Nephritis
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  Primary Objective:; - To describe the incidence rate (IR) of neurotoxicity in LN patients who initiated voclosporin treatment; - To describe the IR of chronic nephrotoxicity in LN patients who initiated voclosporin treatment; - To describe the IR of any malignancies in LN patients who initiated voclosporin treatment; ; Secondary Objective:; To describe the incidence proportions of neurotoxicity, chronic nephrotoxicity, and any malignancies in LN patients who initiated voclosporin