A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
Recruiting · NCT06243731 · Observational (researchers observe without assigning treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
No Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
25 locations listed.
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Queen Elizabeth Hospital Birmingham - Birmingham, United Kingdom
- C.H. Regional Reina Sofia - PPDS - Córdoba, Spain
- King's College Hospital - London, United Kingdom
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Regional Universitario de Malaga Hospital General - Málaga, Spain
- Azienda Ospedaliera Dei Colli - Ospedale Monaldi - Naples, Italy
- Fondazione IRCCS Policlinico San Matteo - Pavia, Italy
- Hospital Universitario Virgen del Rocio - PPDS - Seville, Spain
- Tartu University Hospital - Tartu, Estonia
- Wrexham Maelor Hospital - Wrexham, United Kingdom
- Hospital Universitario de Bellvitge - L'Hospitalet de Llobregat, Barcelona, Spain
- Universitatsklinikum Wurzburg - Würzburg, Bavaria, Germany
- Hopital Erasme - PPDS - Anderlecht, Brussels Capital, Belgium
- Dorset County Hospital - Dorchester, Dorset, United Kingdom
- CHU de Brest - Hopital La Cavale Blanche - Brest, Finistere, France
- CHU de Bordeaux - Hopital Pellegrin - Bordeaux, Gironde, France
- North Estonia Medical Centre Foundation - Tallinn, Harju, Estonia
- CHU de Montpellier - Hopital Lapeyronie - Montpellier, Herault, France
- CHU de Grenoble Alpes - Hopital Michallon - La Tronche, Isere, France
- Universitatsklinikum Leipzig - Leipzig, Saxony, Germany
- AP-HP - Hopital Henri Mondor - Créteil, Val-de-Marne, France
- Hospital Universitario Cruces - Barakaldo, Vizcaya, Spain
- UZ Leuven - PPDS - Leuven, Vlaams Brabant, Belgium