Clinical trial Recruiting at 9 sites Observational Ages 18 and up

Maribavir for CMV in adults with kidney failure after transplantation

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

Run by Takeda · NCT06243731 · Data updated 2026-11-12

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.

More Kidney Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorTakeda
Industry-sponsored
Locations25 sites (Anderlecht, Brussels Capital and 24 other locations)
StatusRecruiting
StartedNovember 3, 2025
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2027
Registry record updatedDecember 16, 2025
Trial IDNCT06243731 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • North Estonia Medical Centre Foundation
    Tallinn, Harju, Estonia
    Recruiting
  • Tartu University Hospital
    Tartu, Estonia
    Recruiting
  • CHU de Brest - Hopital La Cavale Blanche
    Brest, Finistere, France
    Recruiting
  • CHU de Bordeaux - Hopital Pellegrin
    Bordeaux, Gironde, France
    Recruiting
  • CHU de Montpellier - Hopital Lapeyronie
    Montpellier, Herault, France
    Recruiting
  • CHU de Grenoble Alpes - Hopital Michallon
    La Tronche, Isere, France
    Recruiting
Show 19 more locations
  • AP-HP - Hopital Henri Mondor
    Créteil, Val-de-Marne, France
    Recruiting
  • Hospital Universitario Vall d'Hebron - PPDS
    Barcelona, Spain
    Recruiting
  • Hospital Regional Universitario de Malaga Hospital General
    Málaga, Spain
    Recruiting
  • Hopital Erasme - PPDS
    Anderlecht, Brussels Capital, Belgium
    Not yet recruiting
  • UZ Leuven - PPDS
    Leuven, Vlaams Brabant, Belgium
    Not yet recruiting
  • Universitatsklinikum Wurzburg
    Würzburg, Bavaria, Germany
    Not yet recruiting
  • Universitatsklinikum Leipzig
    Leipzig, Saxony, Germany
    Not yet recruiting
  • Azienda Ospedaliera Dei Colli - Ospedale Monaldi
    Naples, Italy
    Not yet recruiting
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, Italy
    Not yet recruiting
  • Hospital Universitario de Bellvitge
    L'Hospitalet de Llobregat, Barcelona, Spain
    Not yet recruiting
  • Hospital Universitario Cruces
    Barakaldo, Vizcaya, Spain
    Not yet recruiting
  • Hospital Clinic de Barcelona
    Barcelona, Spain
    Not yet recruiting
  • C.H. Regional Reina Sofia - PPDS
    Córdoba, Spain
    Not yet recruiting
  • Hospital Universitario Ramon y Cajal
    Madrid, Spain
    Not yet recruiting
  • Hospital Universitario Virgen del Rocio - PPDS
    Seville, Spain
    Not yet recruiting
  • Dorset County Hospital
    Dorchester, Dorset, United Kingdom
    Not yet recruiting
  • Queen Elizabeth Hospital Birmingham
    Birmingham, United Kingdom
    Not yet recruiting
  • King's College Hospital
    London, United Kingdom
    Not yet recruiting
  • Wrexham Maelor Hospital
    Wrexham, United Kingdom
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.