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
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
Hopital Erasme - PPDS
NOT_YET_RECRUITING
Anderlecht
UZ Leuven - PPDS
NOT_YET_RECRUITING
Leuven
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
France
CHU de Bordeaux - Hopital Pellegrin
RECRUITING
Bordeaux
CHU de Brest - Hopital La Cavale Blanche
RECRUITING
Brest
AP-HP - Hopital Henri Mondor
RECRUITING
Créteil
CHU de Grenoble Alpes - Hopital Michallon
RECRUITING
La Tronche
CHU de Montpellier - Hopital Lapeyronie
RECRUITING
Montpellier
Germany
Universitatsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitatsklinikum Wurzburg
NOT_YET_RECRUITING
Würzburg
Italy
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
NOT_YET_RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Spain
Hospital Universitario Cruces
NOT_YET_RECRUITING
Barakaldo
Hospital Clinic de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
C.H. Regional Reina Sofia - PPDS
NOT_YET_RECRUITING
Córdoba
Hospital Universitario de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Ramon y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Regional Universitario de Malaga Hospital General
RECRUITING
Málaga
Hospital Universitario Virgen del Rocio - PPDS
NOT_YET_RECRUITING
Seville
United Kingdom
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
Dorset County Hospital
NOT_YET_RECRUITING
Dorchester
King's College Hospital
NOT_YET_RECRUITING
London
Wrexham Maelor Hospital
NOT_YET_RECRUITING
Wrexham
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2025-11-03
Estimated Completion Date:2027-01-31
Participants
Target number of participants:10
Treatments
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.