A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

December 8, 2025 updated by: Takeda

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Not yet recruiting
        • Hôpital Erasme - PPDS
        • Principal Investigator:
          • Maya Hites
        • Contact:
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven - PPDS
        • Contact:
        • Principal Investigator:
          • Dirk Kuypers
  • Estonia
      • Tartu, Estonia, 60535
        • Recruiting
        • Tartu University Hospital
        • Contact:
        • Principal Investigator:
          • Mai Rosenberg
    • Harju
      • Tallinn, Harju, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation
        • Contact:
        • Principal Investigator:
          • Kadri Lilienthal
  • France
    • Finistere
      • Brest, Finistere, France, 29200
        • Recruiting
        • CHU de Brest - Hôpital La Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Yannick Le Meur
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • CHU de Bordeaux - Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • Hannah Kaminski
    • Herault
      • Montpellier, Herault, France, 34090
        • Recruiting
        • CHU de Montpellier - Hôpital Lapeyronie
        • Principal Investigator:
          • Laurene Tardieu
        • Contact:
    • Isere
      • La Tronche, Isere, France, 38700
        • Recruiting
        • CHU de Grenoble Alpes - Hôpital Michallon
        • Principal Investigator:
          • Olivier Epaulard
        • Contact:
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Recruiting
        • AP-HP - Hôpital Henri Mondor
        • Principal Investigator:
          • Antoine DURRBACH
        • Contact:
  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Not yet recruiting
        • Universitätsklinikum Würzburg
        • Principal Investigator:
          • Daniel Teschner
        • Contact:
    • Saxony
      • Leipzig, Saxony, Germany, 4103
  • Italy
      • Napoli, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliera Dei Colli - Ospedale Monaldi
        • Contact:
        • Principal Investigator:
          • Emanuele Durante-Mangoni
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Teresa Rampino
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
        • Contact:
        • Principal Investigator:
          • Oscar Len
      • Barcelona, Spain, 8036
        • Not yet recruiting
        • Hospital Clinic De Barcelona
        • Principal Investigator:
          • Fritz Diekmann
        • Contact:
      • Córdoba, Spain, 14004
      • Madrid, Spain, 28304
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • Pilar Martin Davila
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga Hospital General
        • Contact:
        • Principal Investigator:
          • Veronica Lopez Jimenez
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
        • Contact:
        • Principal Investigator:
          • Gabriel Bernal Blanco
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Not yet recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Ariadna Padulles Zamora
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Not yet recruiting
        • Hospital Universitario Cruces
        • Contact:
        • Principal Investigator:
          • Ane Josune Goikoetxea Agirre
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Not yet recruiting
        • Queen Elizabeth Hospital Birmingham
        • Principal Investigator:
          • Bhuvan Kishore
        • Contact:
      • London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • King's College Hospital
        • Principal Investigator:
          • Sapna Shah
        • Contact:
      • Wrexham, United Kingdom, LL13 7TD
        • Not yet recruiting
        • Wrexham Maelor Hospital
        • Contact:
        • Principal Investigator:
          • Stuart Robertson
    • Dorset
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Not yet recruiting
        • Dorset County Hospital
        • Contact:
        • Principal Investigator:
          • Joanne Taylor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: 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)
An AESI is defined as AEs that will be specifically highlighted to the Investigator. AESIs are as follows: Immunosuppressant drug concentration level increased, tissue-invasive CMV disease, relapse or progression of the underlying disease for which the transplant was performed, taste disturbance (dysgeusia), Nausea, vomiting, diarrhea, invasive fungal or bacterial infections, graft-versus-host-disease (GVHD), leukopenia including neutropenia, lymphocytopenia, and low white blood cell (WBC) count, anemia including low hemoglobin and thrombocytopenia including low platelets count.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-620-4007
  • EUPAS1000000006 (Registry Identifier: EUPAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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