EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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EBV Infection EBV Viremia Epstein-Barr Virus Associated Lymphoproliferative Disorder Post-transplant Lymphoproliferative Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney transplant recipients

Adults and children undergoing kidney transplantation in Norway and the western part of Denmark.

EBV DNA in whole blood and plasma

Intervention Type DIAGNOSTIC_TEST

Consecutive measurements of EBV DNA in whole blood and plasma

Interventions

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EBV DNA in whole blood and plasma

Consecutive measurements of EBV DNA in whole blood and plasma

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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).