NCT00886158

Brief Summary

Viral infections are an important complication of transplantation. Immunosuppressive therapy interferes with T cell immunity resulting in a high incidence of viral infection. Newer agents, such as mycophenolate mofetil (MMF) and sirolimus, have been associated with an increased risk of herpes virus infection. The introduction of these more potent immunosuppressive agents over the past decade correlates with an increase in the rate of hospitalizations of transplant patients with infections. This prospective study will determine the role of sub-clinical herpes virus infections in the development of complications such as chronic allograft nephropathy (CAN) and Post Transplant Lymphoproliferative Disease (PTLD). By focusing on treatable herpes virus infections, these studies have the potential to identify therapeutic strategies that can be used to diminish the burden of graft loss from CAN, significantly improving renal allograft survival and quality of life in transplant patients. Future specific interventions to test the hypothesis of a direct causal relationship between sub-clinical herpes virus infection and CAN may include the use of anti-viral therapy in response to sub-clinical infection of the renal allograft and/or peripheral blood.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

10.8 years

First QC Date

April 17, 2009

Last Update Submit

July 20, 2011

Conditions

Viral Infections

Keywords

Organ Transplants

Outcome Measures

Primary Outcomes (1)

  • To evaluate real-time quantitative PCR levels of EBV DNA for its ability to diagnose EBV infection (primary infection or reactivation), predict the development of PTLD, and compare the results to present standard of care (semi-quantitative PCR).

    Specimens will be collected at the following time points post-transplant: Week 2, Week 4, Week 8, Week 10, Week 12, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 15, Month 18, Month 21, Month 24

Secondary Outcomes (2)

  • To describe the characteristics of EBV, CMV, HHV-6 and HHV-7 infection in the solid organ transplant population.

    Specimens will be collected at the following time points post-transplant: Week 2, Week 4, Week 8, Week 10, Week 12, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 15, Month 18, Month 21, Month 24

  • To establish a tissue bank for the pediatric solid organ transplant population to allow for timely screening of this high-risk population when new technology becomes available and/or when new infectious agents are discovered

    Specimens are collected at the following timepoints post transplant: 3-6 months, 12 months, and 24 months

Study Arms (1)

Solid Organ Transplant Recipients

Solid organ transplant recipients receiving their care at Seattle Children's Hospital

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Solid organ transplant recipients receiving their care at Seattle Children's Hospital

You may qualify if:

  • Age from birth to 21 years
  • All solid organ transplant recipients receiving their care at Seattle Children's Hospital
  • Signed consent, and when age appropriate, signed assent

You may not qualify if:

  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, kidney biopsy tissue

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Jodi Smith, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodi Smith, MD, MPH

CONTACT

206-987-2524jodi.smith@seattlechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 22, 2009

Study Start

June 1, 2001

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

US(1)