EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients
Recruitment status was Active, not recruiting
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 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|
- 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 ] [ Designated as safety issue: No ]
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
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963248
|Heidelberg, Germany, 69120|
|Principal Investigator:||Burkhard Toenshoff, MD, PhD||University Children's Hospital of Heidelberg|