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NCT Number: NCT04189835

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

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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Key information

Conditions

EBV Infection DNA Virus Infections EBV Viremia Epstein-Barr Virus Associated Lymphoproliferative Disorder Epstein-Barr Virus Infections Herpesviridae Infections Infections Post-transplant Lymphoproliferative Disorder Tumor Virus Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Central Region Denmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Exclusion criteria

  • Patients unable to comply with the study requirements.
  • Withdrawal of consent.

Treatment and study plan

EBV DNA in whole blood and plasma

Diagnostic Test

Consecutive measurements of EBV DNA in whole blood and plasma

Primary outcomes

  1. The incidence rate of EBV driven PTLD

    Time frame: 2 years

    The incidence rate of EBV driven PTLD in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia). The detection level for EBV DNA in the whole blood is 110 IU/ml. Levels of EBV DNA < 1000 IU/ml are not quantified. The lower limit of detection for the EBV DNA plasma analysis is 25 IU/ml. Levels of EBV < 100 IU/ml are not quantified

  2. The incidence rate of infections requiring hospitalisation in patients with persistant EBV DNAemia

    Time frame: 2 years

    The incidence rate of infections requiring hospitalisation in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia).

  3. Mortality rate in patients with persistant EBV DNAemia

    Time frame: 2 years

    Mortality rate in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia).

Secondary outcomes

  1. The incidence of symptomatic opportunistic infections

    Time frame: 2 years

    Defined as CMV, BK virus, Herpes simplex virus 1 and 2, Human herpes virus 6 and 7, and Varicella zoster virus. In addition, bacterial pathogens such as Legionella pneumophila, Listeria monocytogenes, Mycobacterium tuberculosis, Nocardia, all parasitic infections i.e. Pneumocystis jirovecii and fungal infections are regarded as opportunistic infections.

  2. Incidence of infections requiring hospitalisation

    Time frame: 2 years

  3. Incidence of EBV driven PTLD during follow-up.

    Time frame: 2 years

    PTLD verified by a biopsy. Cases of PTLD will be reviewed according to the WHO-definitions

  4. Incidence of acute rejection

    Time frame: 2 years

    The incidence of acute rejection and chronic graft changes will be evaluated according to the Banff classification system. Cases without a biopsy will be registered if they have been treated as a an acute rejection

  5. Kidney graft function

    Time frame: 2 years

    Kidney graft function at 2, 6, 12 and 24 months after transplantation will be evaluated by estimated glomerular filtration rate (eGFR, mL/min.) and urine albumin/creatinine

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Odense University Hospital
  • Rikshospitalet University Hospital

Registry information

Official study title

EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients - Early Identification of Increased Risk of Infection and Cancer for Individualised Immunosuppression.

Acronym: EVITA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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