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Reviews safety of maribavir in adults with kidney failure and CMV infection after transplant

Reviews medical records on maribavir safety in adults with kidney failure and CMV infection.

Key facts

Who runs it
Takeda
Where
Birmingham, Dorchester, London, and Wrexham, United KingdomSee the 4 sitesAlso in 6 other countries, 21 sites
Trial code
Registry title
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Status
Recruiting
People taking part
10 people, planned
Started
3 Nov 2025
Expected to end
31 Jan 2027
Type of study
Observational
Record updated
16 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe kidney disease or kidney failure who had a transplant and then got a CMV infection that did not respond to treatment. They must have started maribavir in routine care. Only existing medical records are reviewed.

Age
18 years or older
Sex
All sexes can join
Disease stage
Kidney failure (ESRD, eGFR below 15 mL/min/1.73m^2, including people on peritoneal dialysis or hemodialysis) or severe chronic kidney disease (eGFR 15 to below 30 mL/min/1.73m^2), diagnosed before the index date. CMV infection that did not respond to treatment (refractory) after transplant.
Earlier treatment
Must have had a solid organ transplant or a stem cell transplant before the index date. Must have started maribavir in routine practice and received at least 1 dose.
Biomarker or test result
eGFR below 15 mL/min/1.73m^2 for kidney failure, or 15 to below 30 mL/min/1.73m^2 for severe chronic kidney disease.

Main reasons for not taking part

  • The record lists no exclusion criteria

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • There are no exclusion criteria for this study

Where in United Kingdom

Also in 6 other countries, 21 sites

  • Queen Elizabeth Hospital BirminghamBirmingham, United KingdomContact: Bhuvan Kishore (principal investigator)Not yet recruiting
  • Dorset County HospitalDorchester, United KingdomContact: Joanne Taylor (principal investigator)Not yet recruiting
  • King's College HospitalLondon, United KingdomContact: Sapna Shah (principal investigator)Not yet recruiting
  • Wrexham Maelor HospitalWrexham, United KingdomContact: Stuart Robertson (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).

Read full original descriptionShow less

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.

The group in the trial

  • All Participants With Kidney Failure

    The study cohort will comprise of participants aged 18 years or older treated with maribavir for a refractory CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis. Data from eligible participants will be assessed from index date (Day 0: the day of initiation of the first maribavir treatment course during the eligibility period) until 7 days after the date of the end of supply of the last prescription of treatment or date of death or end of data availability, or treatment completion/discontinuation whichever occurs first.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Reviews safety of maribavir in adults with kidney failure and CMV infection after transplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 December 2025