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

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ClinicalTrials.gov Identifier: NCT00963248
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin

Brief Summary:

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.


Condition or disease
Epstein-Barr Virus Infections

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.

Study Type : Observational
Actual Enrollment : 106 participants
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
Study Start Date : July 2003
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 ]

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


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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963248


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Britta Hoecker, EBV in pediatric RTx patients, Klinik für Kinder- und Jugendmedizin
ClinicalTrials.gov Identifier: NCT00963248     History of Changes
Other Study ID Numbers: BToenshoff002
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections