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

This study has been completed.
Information provided by (Responsible Party):
Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin Identifier:
First received: August 20, 2009
Last updated: April 10, 2015
Last verified: April 2015


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.

Epstein-Barr Virus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study

Resource links provided by NLM:

Further study details as provided by Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
EDTA plasma for EB viral load, serum for differentiated serology and sodium heparine whole-blood for EBV-specific t cells

Enrollment: 106
Study Start Date: July 2003
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric (< 18 years) and adult (>= 18 years) kidney allograft recipients

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
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Please refer to this study by its identifier: NCT00963248

Britta Hoecker
Heidelberg, Germany, 69120
Sponsors and Collaborators
Klinik für Kinder- und Jugendmedizin
Principal Investigator: Burkhard Toenshoff, MD, PhD University Children's Hospital of Heidelberg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. med. Britta Hoecker, EBV in pediatric RTx patients, Klinik für Kinder- und Jugendmedizin Identifier: NCT00963248     History of Changes
Other Study ID Numbers: BToenshoff002
Study First Received: August 20, 2009
Last Updated: April 10, 2015

Keywords provided by Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin:

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections processed this record on May 25, 2017