EVITA Study - Epstein-Barr Virus Infection MoniToring in RenAl Transplant Recipients

Last updated: November 26, 2024
Sponsor: University of Aarhus
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Treatment

EBV DNA in whole blood and plasma

Clinical Study ID

NCT04189835
EBV Renal
  • Ages > 2
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children from 2 years of age receiving a kidney transplant from a living or deceaseddonor.

  • Adults 18 years or older who receive a kidney transplant from a living or deceaseddonor.

  • Capable of giving written informed consent to participation in the study (legalguardians capable of giving written informed consent to participation in the studyin case of children younger than 18 years old).

Exclusion

Exclusion Criteria:

  • Patients unable to comply with the study requirements.

  • Withdrawal of consent.

Study Design

Total Participants: 509
Treatment Group(s): 1
Primary Treatment: EBV DNA in whole blood and plasma
Phase:
Study Start date:
January 03, 2020
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Aarhus University Hospital

    Aarhus, Central Region Denmark
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, Region of Southern Denmark
    Denmark

    Site Not Available

  • Rikshospitalet, Oslo Universitetssykehus

    Oslo,
    Norway

    Site Not Available

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