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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Klinik für Kinder- und Jugendmedizin.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Klinik für Kinder- und Jugendmedizin
ClinicalTrials.gov Identifier:
NCT00963248
First received: August 20, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition
Epstein-Barr Virus Infections

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Klinik für Kinder- und Jugendmedizin:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric (< 18 years) and adult (>= 18 years) kidney allograft recipients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963248

Locations
Germany
Britta Hoecker
Heidelberg, Germany, 69120
Sponsors and Collaborators
Klinik für Kinder- und Jugendmedizin
Investigators
Principal Investigator: Burkhard Toenshoff, MD, PhD University Children's Hospital of Heidelberg
  More Information

No publications provided by Klinik für Kinder- und Jugendmedizin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Burkhard Toenshoff, University Children's Hospital of Heidelberg
ClinicalTrials.gov Identifier: NCT00963248     History of Changes
Other Study ID Numbers: BToenshoff002
Study First Received: August 20, 2009
Last Updated: August 20, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Klinik für Kinder- und Jugendmedizin:
EBV
PTLD
RTx
pediatric

Additional relevant MeSH terms:
Virus Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections
Neoplasms, Experimental
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014