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Maribavir for CMV in adults with kidney failure after transplantation

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

Observational Takeda · NCT06243731

This project will see if maribavir is safe for adults with severe kidney failure (including people on dialysis) who develop CMV after a transplant by reviewing existing medical records.

Quick facts

Study typeObservational
Enrollment10 (estimated)
Ages18 Years and up
SexAll
SponsorTakeda Industry-sponsored
Locations25 sites (Anderlecht, Brussels Capital and 24 other locations)
Trial IDNCT06243731 on ClinicalTrials.gov

What this trial studies

This is an observational, retrospective chart-review of adults with severe chronic kidney disease or end-stage renal disease who received maribavir for refractory CMV after a solid organ or stem cell transplant. The study collects data already recorded during routine clinical care and does not change participants' treatment. Eligibility requires prior transplant, documented refractory CMV, severe CKD (eGFR 15–<30) or ESRD (eGFR <15 or on dialysis), and at least one dose of maribavir given in routine practice. The primary focus is safety in this high-risk kidney-impaired population across several European transplant centers.

Who should consider this trial

Good fit: Adults (≥18) who previously had a solid organ or hematopoietic stem cell transplant, developed refractory CMV in the post-transplant period, have severe CKD (eGFR 15–<30) or ESRD (eGFR <15 or on dialysis), and received at least one dose of maribavir in routine care.

Not a fit: Patients without severe kidney impairment, those who never received maribavir, or those whose CMV was not refractory are not represented and are unlikely to benefit directly from these specific findings.

Why it matters

Potential benefit: If successful, the results could give clinicians better information about maribavir's safety in transplant patients with severe kidney impairment and support safer treatment decisions for this vulnerable group.

How similar studies have performed: Randomized trials have shown maribavir is effective for refractory CMV in transplant recipients, but safety data specifically in people with severe CKD or on dialysis remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adults more than and equal to (≥) 18 years of age at index date.
* Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.

  * If ESRD (including participants on peritoneal dialysis or hemodialysis): participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\<) 15 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2).
  * If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to \<30 mL/min/1.73m\^2 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.

Where this trial is running

Anderlecht, Brussels Capital and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CytomegalovirusKidney DiseaseKidney FailureDrug therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.