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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963248
Other study ID # BToenshoff002
Secondary ID
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


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
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