Trials / Completed
CompletedNCT04189835
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 509 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- EBV Infection
- EBV Viremia
- Epstein-Barr Virus Associated Lymphoproliferative Disorder
- Post-transplant Lymphoproliferative Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EBV DNA in whole blood and plasma | Consecutive measurements of EBV DNA in whole blood and plasma |
Timeline
- Start date
- 2020-01-03
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2019-12-06
- Last updated
- 2025-11-20
Locations
3 sites across 2 countries: Denmark, Norway
Source: ClinicalTrials.gov record NCT04189835. Inclusion in this directory is not an endorsement.