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

Active, not recruiting

• Conditions: Epstein-Barr Virus Associated Lymphoproliferative Disorder; EBV Infection; Post-transplant Lymphoproliferative Disorder; EBV Viremia
• Interventions: Diagnostic Test: EBV DNA in whole blood and plasma

• Registration Number: NCT04189835
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2020-01-03
• Primary Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 509

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney transplant recipients	EBV DNA in whole blood and plasma	Adults and children undergoing kidney transplantation in Norway and the western part of Denmark.

Primary Outcome Measures

Name	Time	Method
The incidence rate of EBV driven PTLD	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
The incidence rate of infections requiring hospitalisation in patients with persistant EBV DNAemia	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).
Mortality rate in patients with persistant EBV DNAemia	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 Outcome Measures

Name	Time	Method
Incidence of infections requiring hospitalisation	2 years
Incidence of acute rejection	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
The incidence of symptomatic opportunistic infections	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.
Kidney graft function	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
Incidence of EBV driven PTLD during follow-up.	2 years	PTLD verified by a biopsy. Cases of PTLD will be reviewed according to the WHO-definitions

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Region Denmark, Denmark

Odense University Hospital; 🇩🇰 Odense, Region of Southern Denmark, Denmark

Rikshospitalet, Oslo Universitetssykehus; 🇳🇴 Oslo, Norway