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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Locations | 25 sites (Anderlecht, Brussels Capital and 24 other locations) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06243731 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
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Kidney and liver blood flow patterns after major trauma
We will use bedside ultrasound to see whether abnormal kidney and liver blood flow patterns occur in adults admitted to the ICU after major trauma and whether those patterns link to acute kidney injury or the need for mechanical ventilation.
-
Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)
This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.
-
Pedal Pump Device for Lower Extremity Edema in Hospitalized Patients
This study tests a foot-pump device to see if it is tolerable and can help reduce swelling in the legs of hospitalized patients with edema.
-
Adapting and testing PEN-Plus in Zambian primary care
Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.
-
Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers
This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.
-
Impact of a Clinical Information System on hospital outcomes for adults with chronic diseases
This study tests whether implementing a Clinical Information System helps reduce readmissions or death within 30 days after hospital discharge for adults with chronic conditions in Alberta.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.