Actively Recruiting
Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus Infection and Severe Kidney Disease or Kidney Failure Including Dialysis
Led by Takeda · Updated on 2025-12-16
10
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of maribavir in adults who have severe chronic kidney disease (CKD) or end-stage renal disease (ESRD), including those on dialysis, and who have a refractory cytomegalovirus (CMV) infection after transplantation. This observational study collects already existing data from participants' medical records without changing their standard medical care or treatment. The study includes adults aged 18 years or older who have undergone solid organ or stem cell transplantation and have been treated with maribavir for refractory CMV infection. Data will be collected from the start of maribavir treatment through up to seven days after the last dose or until death or end of available data, whichever comes first. Participants include those with severe CKD or ESRD, including those on peritoneal or hemodialysis. Participants' medical records will be reviewed to monitor any adverse events from maribavir treatment during the study period, which can last up to four years. The main measurement is the number of participants experiencing adverse events, including those of special interest. This review will not affect participants' usual care, and no new treatments or interventions will be given as part of this study.
CONDITIONS
Brief Title
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at the start of maribavir treatment
- Diagnosed with comorbid end-stage renal disease (ESRD) confirmed by eGFR less than 15 mL/min/1.73m2 or severe chronic kidney disease (CKD) with eGFR between 15 and less than 30 mL/min/1.73m2
- Have had a solid organ transplant or hematopoietic stem cell transplant before starting maribavir
- Diagnosed with refractory cytomegalovirus (CMV) infection during the latest post-transplant period
- Started maribavir treatment in routine practice and received at least one dose
- Provided informed consent where required before data collection begins
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or chart review)
Duration - Up to 4 years
Participants who have started maribavir treatment for refractory cytomegalovirus infection and have severe kidney disease or kidney failure are observed to assess safety outcomes.
Data collected from medical records during routine care
Trial Site Locations
Total: 25 locations
1
Hopital Erasme - PPDS
Anderlecht, Brussels Capital, Belgium, 1070
Not Yet Recruiting
2
UZ Leuven - PPDS
Leuven, Vlaams Brabant, Belgium, 3000
Not Yet Recruiting
3
North Estonia Medical Centre Foundation
Tallinn, Harju, Estonia, 13419
Actively Recruiting
4
Tartu University Hospital
Tartu, Estonia, 60535
Actively Recruiting
5
CHU de Brest - Hopital La Cavale Blanche
Brest, Finistere, France, 29200
Actively Recruiting
6
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, Gironde, France, 33000
Actively Recruiting
7
CHU de Montpellier - Hopital Lapeyronie
Montpellier, Herault, France, 34090
Actively Recruiting
8
CHU de Grenoble Alpes - Hopital Michallon
La Tronche, Isere, France, 38700
Actively Recruiting
9
AP-HP - Hopital Henri Mondor
Créteil, Val-de-Marne, France, 94000
Actively Recruiting
10
Universitatsklinikum Wurzburg
Würzburg, Bavaria, Germany, 97080
Not Yet Recruiting
11
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany, 4103
Not Yet Recruiting
12
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Naples, Italy, 80131
Not Yet Recruiting
13
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Not Yet Recruiting
14
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Not Yet Recruiting
15
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
16
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 8035
Actively Recruiting
17
Hospital Clinic de Barcelona
Barcelona, Spain, 8036
Not Yet Recruiting
18
C.H. Regional Reina Sofia - PPDS
Córdoba, Spain, 14004
Not Yet Recruiting
19
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28304
Not Yet Recruiting
20
Hospital Regional Universitario de Malaga Hospital General
Málaga, Spain, 29010
Actively Recruiting
21
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Not Yet Recruiting
22
Dorset County Hospital
Dorchester, Dorset, United Kingdom, DT1 2JY
Not Yet Recruiting
23
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
24
King's College Hospital
London, United Kingdom, SE5 9RS
Not Yet Recruiting
25
Wrexham Maelor Hospital
Wrexham, United Kingdom, LL13 7TD
Not Yet Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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