Menu
Recruiting NCT06243731

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

— Observational Cytomegalovirus (CMV) Kidney Disease Kidney Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: Cytomegalovirus (CMV), Kidney Disease, Kidney Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Estonia, France, Germany, Italy +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other No Intervention
    This is a non-interventional study.

Primary outcome measures

  • 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)]
Secondary outcome measures (1)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 8 centers
  • Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Universitario Cruces — Barakaldo
  • Hospital Universitario Vall d'Hebron - PPDS — Barcelona
  • Hospital Clinic de Barcelona — Barcelona
  • C.H. Regional Reina Sofia - PPDS — Córdoba
  • Hospital Universitario Ramon y Cajal — Madrid
  • Hospital Regional Universitario de Malaga Hospital General — Málaga
  • Hospital Universitario Virgen del Rocio - PPDS — Seville
France · 5 centers
  • CHU de Brest - Hopital La Cavale Blanche — Brest
  • CHU de Bordeaux - Hopital Pellegrin — Bordeaux
  • CHU de Montpellier - Hopital Lapeyronie — Montpellier
  • CHU de Grenoble Alpes - Hopital Michallon — La Tronche
  • AP-HP - Hopital Henri Mondor — Créteil
United Kingdom · 4 centers
  • Dorset County Hospital — Dorchester
  • Queen Elizabeth Hospital Birmingham — Birmingham
  • King's College Hospital — London
  • Wrexham Maelor Hospital — Wrexham
Belgium · 2 centers
  • Hopital Erasme - PPDS — Anderlecht
  • UZ Leuven - PPDS — Leuven
Estonia · 2 centers
  • North Estonia Medical Centre Foundation — Tallinn
  • Tartu University Hospital — Tartu
Germany · 2 centers
  • Universitatsklinikum Wurzburg — Würzburg
  • Universitatsklinikum Leipzig — Leipzig
Italy · 2 centers
  • Azienda Ospedaliera Dei Colli - Ospedale Monaldi — Naples
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT06243731 · TAK-620-4007 · EUPAS1000000006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗