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OpenTrials
Completed

NCT Number: NCT00963248

EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients

Question:

In which stage of an EBV-infection is a selective reduction of immunosuppressive medication reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of acute rejection episodes due to under immunosuppression?

Aim of study:

Identification of patients at high-risk for PTLD.

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Key information

Conditions

Epstein-Barr Virus Infections DNA Virus Infections Herpesviridae Infections Infections Tumor Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Britta Hoecker

Heidelberg, 69120, Germany

About this study

PTLD represents a heterogeneous group of abnormal lymphoid proliferations, generally of B-cells, that occur in the setting of ineffective T-cell function because of pharmacological immunosuppression. Because the vast majority of PTLDs are associated with Epstein-Barr virus (EBV) infection, surveillance of EBV infection may have the potential to prevent the development of PTLD by early intervention. However, the cut-off values of "high" EBV viral load remain badly defined due to a lack of prospective studies and assay standardization. The aim of this ongoing multicenter prospective study is the serial detection of primary EBV infection or reactivation in a homogeneous patient population of pediatric renal transplant recipients during the first 2 years posttransplant by the combined analysis of quantitative EBV viral load by a standardized quantitative PCR technique, EBV serology and EBV-specific T-lymphocytes for the identification of high-risk patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male and female pediatric and adult renal transplant recipients with written informed consent

Exclusion criteria

  • psychological illness which does not allow patient to understand the study and participate following his own free will
  • no written informed consent

Treatment and study plan

Primary outcomes

  1. EB viral load, serology and EBV-specific T cell in pediatric (and adult) renal transplant recipients with or without clinical symptoms of EBV, PTLD etc.

    Time frame: 9 years

Sponsors and collaborators

Lead sponsor

Klinik für Kinder- und Jugendmedizin

Other

Registry information

Official study title

Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2009
Registry last updated
Apr 13, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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