Clinical Trials in Italy / NCT06243731
Recruiting
Observational
A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation
NCT06243731 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Cytomegalovirus (CMV)Kidney DiseaseKidney Failure
Investigational drug(s) / intervention(s)
No Intervention
No Intervention: This is a non-interventional study.
Study 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
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.
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) — 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.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopital Erasme - PPDS | Anderlecht | Brussels Capital | Not Yet Recruiting |
| UZ Leuven - PPDS | Leuven | Vlaams Brabant | Not Yet Recruiting |
| North Estonia Medical Centre Foundation | Tallinn | Harju | Recruiting |
| Tartu University Hospital | Tartu | Estonia | Recruiting |
| CHU de Brest - Hopital La Cavale Blanche | Brest | Finistere | Recruiting |
| CHU de Bordeaux - Hopital Pellegrin | Bordeaux | Gironde | Recruiting |
| CHU de Montpellier - Hopital Lapeyronie | Montpellier | Herault | Recruiting |
| CHU de Grenoble Alpes - Hopital Michallon | La Tronche | Isere | Recruiting |
| AP-HP - Hopital Henri Mondor | Créteil | Val-de-Marne | Recruiting |
| Universitatsklinikum Wurzburg | Würzburg | Bavaria | Not Yet Recruiting |
| Universitatsklinikum Leipzig | Leipzig | Saxony | Not Yet Recruiting |
| Azienda Ospedaliera Dei Colli - Ospedale Monaldi | Naples | Italy | Not Yet Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Not Yet Recruiting |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Not Yet Recruiting |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | Not Yet Recruiting |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not Yet Recruiting |
| C.H. Regional Reina Sofia - PPDS | Córdoba | Spain | Not Yet Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Not Yet Recruiting |
| Hospital Regional Universitario de Malaga Hospital General | Málaga | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | Spain | Not Yet Recruiting |
| Dorset County Hospital | Dorchester | Dorset | Not Yet Recruiting |
| Queen Elizabeth Hospital Birmingham | Birmingham | United Kingdom | Not Yet Recruiting |
| King's College Hospital | London | United Kingdom | Not Yet Recruiting |
| Wrexham Maelor Hospital | Wrexham | United Kingdom | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06243731 on ClinicalTrials.gov ↗ ← All trials in Italy