A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
NCT ID: NCT06243731
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2025-11-03
2027-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Hopital Erasme - PPDS
Anderlecht, Brussels Capital, Belgium
UZ Leuven - PPDS
Leuven, Vlaams Brabant, Belgium
North Estonia Medical Centre Foundation
Tallinn, Harju, Estonia
Tartu University Hospital
Tartu, , Estonia
CHU de Brest - Hopital La Cavale Blanche
Brest, Finistere, France
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, Gironde, France
CHU de Montpellier - Hopital Lapeyronie
Montpellier, Herault, France
CHU de Grenoble Alpes - Hopital Michallon
La Tronche, Isere, France
AP-HP - Hopital Henri Mondor
Créteil, Val-de-Marne, France
Universitatsklinikum Wurzburg
Würzburg, Bavaria, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Dorset County Hospital
Dorchester, Dorset, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
King's College Hospital
London, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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EUPAS1000000006
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-620-4007
Identifier Type: -
Identifier Source: org_study_id