RecruitingNCT06243731

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

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


Sponsor

Takeda

Enrollment

10 participants

Start Date

Nov 3, 2025

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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.

Interventions

OTHERNo Intervention

This is a non-interventional study.


Locations(25)

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

View Full Details on ClinicalTrials.gov

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NCT06243731


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