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

Epstein-Barr Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963248
• Other study ID #: BToenshoff002
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: April 10, 2015
• Start date: July 2003
• Est. completion date: August 2010

Study information

• Verified date: April 2015
• Source: Klinik für Kinder- und Jugendmedizin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epstein-Barr Virus Infections
• Infection
• Virus Diseases

Locations

Country	Name	City	State
Germany	Britta Hoecker	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kinder- und Jugendmedizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		9 years	No