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

NCT04189835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 509

Last updated 2025-11-20

No results posted yet for this study

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

DIAGNOSTIC_TEST

EBV DNA in whole blood and plasma

Consecutive measurements of EBV DNA in whole blood and plasma

Sponsors & Collaborators

  • Rikshospitalet University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Bente Jespersen, Professor · Aarhus University Hospital

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Denmark
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189835 on ClinicalTrials.gov