A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection 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
2 other identifiers
observational
10
6 countries
17
Brief Summary
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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2025
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedStudy Start
First participant enrolled
November 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
December 16, 2025
December 1, 2025
1.2 years
January 29, 2024
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event.
Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years)
Secondary Outcomes (1)
Number of Participants With Adverse Events of Special Interest (AESIs)
Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years)
Study Arms (1)
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.
Interventions
Eligibility Criteria
Participants treated with maribavir for a refractory (with or without resistance) CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (25)
Hopital Erasme - PPDS
Anderlecht, Brussels Capital, 1070, Belgium
UZ Leuven - PPDS
Leuven, Vlaams Brabant, 3000, Belgium
North Estonia Medical Centre Foundation
Tallinn, Harju, 13419, Estonia
Tartu University Hospital
Tartu, 60535, Estonia
CHU de Brest - Hopital La Cavale Blanche
Brest, Finistere, 29200, France
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, Gironde, 33000, France
CHU de Montpellier - Hopital Lapeyronie
Montpellier, Herault, 34090, France
CHU de Grenoble Alpes - Hopital Michallon
La Tronche, Isere, 38700, France
AP-HP - Hopital Henri Mondor
Créteil, Val-de-Marne, 94000, France
Universitatsklinikum Wurzburg
Würzburg, Bavaria, 97080, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 4103, Germany
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Naples, 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28304, Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Dorset County Hospital
Dorchester, Dorset, DT1 2JY, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Wrexham Maelor Hospital
Wrexham, LL13 7TD, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 6, 2024
Study Start
November 3, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.