Study of Subclinical Viral Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Seattle Children's Hospital
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Jodi Smith, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01615341
First received: June 6, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

Chronic allograft injury is the leading cause of graft loss in renal transplantation. The shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. Strategies to prolong graft survival are urgently needed. The pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. The hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. The young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. The studies outlined will determine the temporal relationship betWeween subclinical viremia, renal allograft infection and allograft injury. This will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. The investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. In addition, the role of virus specific T cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. These data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. Importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. Thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.


Condition
Kidney Transplantation
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subclinical Viral Infection and Renal Allograft Injury

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Change in measured GFR from baseline [ Time Frame: time of transplant, one time between months 3 and 6, and during months 12, and 24 after the transplant ] [ Designated as safety issue: No ]
    Single infusion of iohexol clearance to measure GFR


Secondary Outcome Measures:
  • Change in interstitial fibrosis and tubular atrophy of renal allograft from baseline [ Time Frame: Renal biopsies will be performed at time of transplant, 3-6 m, 12m, and 24m post-transplant. Precise measures of renal function, allograft fibrosis, and innate immune activation will be performed at baseline, 6m, 12, 24m post-transplant. ] [ Designated as safety issue: No ]
  • Change in innate immune activation of renal allograft from baseline [ Time Frame: 6, 12, and 24 months after the transplant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

If participant agrees, blood, tissue, and study data will be banked at Seattle Children's Research Institute.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric and young adult renal transplant recipients (1<25yrs) of their first kidney transplant from Seattle Children's Hospital and University of Washington Medical Center.

Criteria

Inclusion Criteria:

  • Subject and/or parent guardian must be able to understand and provide informed consent or assent
  • Male or Female, Seattle Children's Hospital participants must be 1-<21 yrs and University of Washington Medical Center participants 18-25yrs.
  • Diagnosed with End Stage Renal Disease (ESRD)

Exclusion Criteria:

  • Inability or unwillingness of subject and/or parent guardian to provide informed consent
  • Pregnancy
  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: NCT01615341

Contacts
Contact: Jodi Smith, MD 206-987-2524 jodi.smith@seattlechildrens.org
Contact: Shannon Granillo 206-884-1418 shannon.granillo@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Investigators
Principal Investigator: Jodi Smith, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Jodi Smith, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01615341     History of Changes
Other Study ID Numbers: R01DK088914-01a1
Study First Received: June 6, 2012
Last Updated: June 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Seattle Children's Hospital:
Kidney transplantation
Subclinical Viral Infection
Renal Allograft Injury

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Virus Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014