NCT00963248

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Klinik für Kinder- und Jugendmedizin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Epstein-Barr Virus Infections

Timeline

• Start date: 2003-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-08-21
• Last updated: 2015-04-13

Locations

1 site across 1 country: Germany