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

NCT00963248 | Completed DMC

• 1 other identifier: BToenshoff002
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Epstein-Barr Virus Infections

Keywords

EBV; PTLD; RTx; pediatric

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• male and female pediatric and adult renal transplant recipients with written informed consent

You may not qualify if:

• psychological illness which does not allow patient to understand the study and participate following his own free will
• no written informed consent

Sponsors & Collaborators

• Klinik für Kinder- und Jugendmedizin: lead

Study Sites (1)

Britta Hoecker

Heidelberg, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 23042966 DERIVED

• 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.

  PMID: 22533698 DERIVED

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

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Burkhard Toenshoff, MD, PhD

  University Children's Hospital of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EBV in pediatric RTx patients

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: July 1, 2003
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

DE (1)