Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06243731 | NOT YET RECRUITING | Cytomegalovirus (CMV)

A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Sponsor:

Takeda

Brief Summary:

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis). In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

Condition or disease

Cytomegalovirus (CMV)

Kidney Disease

Kidney Failure

Intervention/treatment

No Intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 10 participants
Official Title : Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Endstage Renal Disease (ESRD) or Comorbid Severe Chronic Renal Disease Requiring Peritoneal Dialysis or Hemodialysis
Actual Study Start Date : 2025-05-30
Estimated Primary Completion Date : 2027-01-31
Estimated Study Completion Date : 2027-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adults more than and equal to (≥) 18 years of age at index date
  • * Diagnosis of ESRD or severe chronic renal disease prior to the index date
  • * If ESRD: participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\<) 15 milliliter per minute (mL/min)
  • * If severe chronic renal disease: participant diagnosed with severe chronic renal disease requiring peritoneal dialysis or hemodialysis; participant has an eGFR of 15 to \<30 mL/min at index
  • * Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date
  • * Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period
  • * Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir
  • * Informed consent provided (where required by local regulations) before data collection commences
    • Exclusion Criteria
  • There are no exclusion criteria for this study
    • A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

    Location Details

    NCT06243731

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    No Location Found