Clinical trial NCT00963248: EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients
Official title: Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epstein-Barr Virus Infections
Keywords: EBV
PTLD
RTx
pediatric
Lead sponsor: Klinik für Kinder- und Jugendmedizin
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric (\< 18 years) and adult (\>= 18 years) kidney allograft recipients

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Britta Hoecker
Study officials:
affiliation: University Children's Hospital of Heidelberg
name: Burkhard Toenshoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hocker B, Fickenscher H, Delecluse HJ, Bohm S, Kusters U, Schnitzler P, Pohl M, John U, Kemper MJ, Fehrenbach H, Wigger M, Holder M, Schroder M, Billing H, Fichtner A, Feneberg R, Sander A, Kopf-Shakib S, Susal C, Tonshoff B. Epidemiology and morbidity of Epstein-Barr virus infection in pediatric renal transplant recipients: a multicenter, prospective study. Clin Infect Dis. 2013 Jan;56(1):84-92. doi: 10.1093/cid/cis823. Epub 2012 Oct 5.
citation: Hocker B, Bohm S, Fickenscher H, Kusters U, Schnitzler P, Pohl M, John U, Kemper MJ, Fehrenbach H, Wigger M, Holder M, Schroder M, Feneberg R, Kopf-Shakib S, Tonshoff B. (Val-)Ganciclovir prophylaxis reduces Epstein-Barr virus primary infection in pediatric renal transplantation. Transpl Int. 2012 Jul;25(7):723-31. doi: 10.1111/j.1432-2277.2012.01485.x. Epub 2012 Apr 25.