NCT04189835Completed
EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients
EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients - Early Identification of Increased Risk of Infection and Cancer for Individualised Immunosuppression.
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
Transplant recipients are treated with immunosuppressive drugs to avoid rejection of the transplanted organ. As the medication impairs the immune response, it also increases the risk of serious infections and cancer in transplant recipients compared with the general population. Previous studies have shown a close association between Epstein-Barr virus (EBV) and post transplant lymphoproliferative disorder (PTLD), with frequent demonstration of the virus in lesional tissues. Transplant recipients without evidence of EBV infection prior to transplantation (EBV seronegative) are at particularly high risk of developing PTLD. Other risk factors include a high viral load. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma) or the appropriate clinical action to take if EBV DNAemia is detected. Our aim is to estimate the incidence and clinical consequences of Epstein-Barr virus (EBV) DNAemia in whole blood and plasma in renal transplant recipients, and to determine if persistence of EBV DNAemia can predict excessive immunosuppression as indicated by the incidence of infections requiring hospitalisation, EBV driven PTLD and mortality.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 509 (actual)
- First submitted
- 25 Nov 2019
- Start date
- 3 Jan 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Aarhus
- Diseases
- Childhood cancers
- NCT number
- NCT04189835
What you commit to
- Study type: Observational
- Participants enrolled: 509
- From 3 Jan 2020 to the primary completion date, 31 Dec 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients unable to comply with the study requirements.
- Withdrawal of consent.
Who the study is looking for
- Children from 2 years of age receiving a kidney transplant from a living or deceased donor.
- Adults 18 years or older who receive a kidney transplant from a living or deceased donor.
- Capable of giving written informed consent to participation in the study (legal guardians capable of giving written informed consent to participation in the study in case of children younger than 18 years old).
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Rikshospitalet, Oslo Universitetssykehus Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.