TAK-620-4007: Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LIVTENCITY
• Study drug International non-proprietary name (INN) or common name:
  MARIBAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX) Other antivirals

  Other antivirals
• Additional medical condition(s):
  Kidney failure

Population studied

• Short description of the study population:
  Participants treated with maribavir for a refractory (with or without resistance) CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis.
• Age groups:
  • Adult and elderly population (≥18 years)
• Special population of interest:
  Frail population

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  10

Study design details

• Study design:
  This is an observational, multi country, retrospective, post-authorization safety study (PASS); based on the review of secondary data collected from medical records of transplant recipients.;
• Main study objective:
  To characterize the safety of maribavir as prescribed in routine clinical practice in terms of occurrence of adverse events (AE) in patients with post-transplant refractory CMV infection and comorbid severe CKD or comorbid ESRD, including participants on peritoneal dialysis or hemodialysis.
• Setting:
  This proposed retrospective study will be conducted among eligible patients aged 18 years or older on maribavir treatment with comorbid severe CKD or ESRD within routine clinical practice settings. The source population will comprise of eligible patients across nine European nations. Included patients will contribute data from the start of eligible maribavir treatment to completion, discontinuation, end of study or death, whichever comes first. Data accrual will vary between countries, depending on their respective launch dates for maribavir.
• Comparators:
  None
• Outcomes:
  The primary outcome is to assess the number of participants with adverse events (AEs). The secondary outcomes will assess the number of participants with adverse events of special interest (AESIs).
• Data analysis plan:
  The statistical analysis of the data will be primarily descriptive. Continuous variables will be described by the number of eligible participants, mean, standard deviation or standard error, median, first quartile, third quartile, and minimum and maximum values. Categorical variables will be described by the total number of participants and relative proportion per category.