Cytomegalovirus (CMV)NCT06243731

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

An observational study of Cytomegalovirus (CMV) and Kidney Disease, run by Takeda at 25 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cytomegalovirus (CMV), Kidney Disease, Kidney Failure
How many people: 10 participants
Where: 25 sitesin 7 countries
Study dates: 3 Nov 2025to 31 Jan 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

There are no exclusion criteria for this study.

Trial locations and contacts

25 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

Country

City, postcode or hospital

Sites recruiting now only

25 sites in 7 countries

Spain8 sites, 8 recruiting

Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903
Site Contact, 0034946006000; +34673002105 ext. 2330, anejosune.goikoetxeaagirre@osakidetza.eus
Ane Josune Goikoetxea Agirre
Not yet recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
Site Contact, 0034 932746090, oscar.len@vhir.org
Oscar Len
Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
Site Contact, 0034 932275444, fdiekman@clinic.cat
Fritz Diekmann
Not yet recruiting
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
Site Contact, 0034 691420650, elisa.ruiz.arabi.sspa@juntadeandalucia.es
Elisa Ruiz Arabi
Not yet recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Site Contact, 0034 932607500, apadulles@bellvitgehospital.cat
Ariadna Padulles Zamora
Not yet recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28304
Site Contact, 34913368165, pmartindav@gmail.com
Pilar Martin Davila
Not yet recruiting
Hospital Regional Universitario de Malaga Hospital General
Málaga, 29010
Site Contact, 0034 951291542, verolopezjim@yahoo.es
Veronica Lopez Jimenez
Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Site Contact, 0034 686942900, gabriel.bernal.sspa@juntadeandalucia.es
Gabriel Bernal Blanco
Not yet recruiting

Other trials in Spain

France5 sites, 5 recruiting

CHU de Bordeaux - Hopital Pellegrin
Bordeaux, Gironde, 33000
Site Contact, (+) 33557821333, hannah.kaminski@chu-bordeaux.fr
Hannah Kaminski
Recruiting
CHU de Brest - Hopital La Cavale Blanche
Brest, Finistere, 29200
Site Contact, (+) 33298347061, yannick.lemeur@chu-brest.fr
Yannick Le Meur
Recruiting
AP-HP - Hopital Henri Mondor
Créteil, Val-de-Marne, 94000
Site Contact, (+) 3349814408, antoine.durrbach@aphp.fr
Antoine Durrbach
Recruiting
CHU de Grenoble Alpes - Hopital Michallon
La Tronche, Isere, 38700
Site Contact, +336165748 99; +33476765805, oepaulard@chu-grenoble.fr
Olivier Epaulard
Recruiting
CHU de Montpellier - Hopital Lapeyronie
Montpellier, Herault, 34090
Site Contact, (+)33467335236, laurene.tardieu@chu-montpellier.fr
Laurene Tardieu
Recruiting

Other trials in France

United Kingdom4 sites, 4 recruiting

Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Site Contact, +441214241075, bhuvan.kishore@nhs.net
Bhuvan Kishore
Not yet recruiting
Dorset County Hospital
Dorchester, Dorset, DT1 2JY
Site Contact, +441305251150, Jo.Taylor@dchft.nhs.uk
Joanne Taylor
Not yet recruiting
King's College Hospital
London, SE5 9RS
Site Contact, +442032995658, sapna.shah@nhs.net
Sapna Shah
Not yet recruiting
Wrexham Maelor Hospital
Wrexham, LL13 7TD
Site Contact, +443000858049, stuart.robertson@wales.nhs.uk
Stuart Robertson
Not yet recruiting

Other trials in United Kingdom

Belgium2 sites, 2 recruiting

Hopital Erasme - PPDS
Anderlecht, Brussels Capital, 1070
Site Contact, 32 (0)2 555 59 76, maya.hites@hubruxelles.be
Maya Hites
Not yet recruiting
UZ Leuven - PPDS
Leuven, Vlaams Brabant, 3000
Site Contact, 32 (0)16 34 56 75, dirk.kuypers@uzleuven.be
Dirk Kuypers
Not yet recruiting

Other trials in Belgium

Estonia2 sites, 2 recruiting

North Estonia Medical Centre Foundation
Tallinn, Harju, 13419
Site Contact, +372 617 1215, kadri.lilienthal@regionaalhaigla.ee
Kadri Lilienthal
Recruiting
Tartu University Hospital
Tartu, 60535
Site Contact, +372 731 8276, mai.rosenberg@kliinikum.ee
Mai Rosenberg
Recruiting

Other trials in Estonia

Germany2 sites, 2 recruiting

Universitatsklinikum Leipzig
Leipzig, Saxony, 4103
Site Contact, +49 341 9713020, georg-nikolaus.franke@medizin.uni-leipzig.de
Georg-Nikolaus Franke
Not yet recruiting
Universitatsklinikum Wurzburg
Würzburg, Bavaria, 97080
Site Contact, +49 93120144512, teschner_d@ukw.de
Daniel Teschner
Not yet recruiting

Other trials in Germany

Italy2 sites, 2 recruiting

Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Naples, 80131
Site Contact, 00390817062475, emanuele.durante@unicampania.it
Emanuele Durante-Mangoni
Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Site Contact, 00390382503896, t.rampino@smatteo.pv.it
Teresa Rampino
Not yet recruiting

Other trials in Italy

About this study

Official title: 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

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.

Conditions: Cytomegalovirus (CMV), Kidney Disease, Kidney Failure
Being tested: No Intervention
Keywords: Drug therapy
Medical subject headings: Kidney Diseases, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No InterventionOther
This is a non-interventional study.

Study groups in NCT06243731
Study group	Role	What they receive
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. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202531 Jan 2027

First posted6 Feb 2024
Study start3 Nov 2025
Primary completion31 Jan 2027 (estimated)
Study completion31 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06243731
Sponsor's protocol ID: TAK-620-4007
Other IDs: EUPAS1000000006
Status last verified: Dec 2025
First submitted: 29 Jan 2024
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 3
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Cytomegalovirus (CMV), Kidney Transplant; Complications
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease

All Cytomegalovirus (CMV) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06243731
Acronym / sponsor ID: TAK-620-4007
Conditions: Cytomegalovirus (CMV), Kidney Disease, Kidney Failure
Keywords: Drug therapy
Study type: Observational
Recruitment status: Recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 3 Nov 2025 (actual)
Primary completion: 31 Jan 2027 (estimated)
Study completion: 31 Jan 2027 (estimated)
First posted: 6 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
All Participants With Kidney Failure	–	Other: No InterventionThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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.
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.

Key exclusion criteria (1 listed)

There are no exclusion criteria for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No InterventionThis is a non-interventional study.	Other	All Participants With Kidney Failure

Primary outcome

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.

1 secondary outcome

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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Cytomegalovirus (CMV)

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 3
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Cytomegalovirus (CMV), Kidney Transplant; Complications
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

Study Director study director

Takeda

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cytomegalovirus (CMV) and Kidney Disease, run by Takeda at 25 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Spain, France, United Kingdom, Belgium, Estonia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06243731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.