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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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