Study of Subclinical Viral Infection

Kidney Transplantation Clinical Trial

Official title:

Subclinical Viral Infection and Renal Allograft Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01615341
• Other study ID #: R01DK088914-01A1
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2012
• Last updated: June 7, 2012
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: June 2012
• Source: Seattle Children's Hospital
• Contact: Jodi Smith, MD
• Phone: 206-987-2524
• Email: jodi.smith[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 25 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Kidney Transplantation
• Renal Insufficiency
• Virus Diseases

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measured GFR from baseline	Single infusion of iohexol clearance to measure GFR	time of transplant, one time between months 3 and 6, and during months 12, and 24 after the transplant	No
Secondary	Change in interstitial fibrosis and tubular atrophy of renal allograft from baseline		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.	No
Secondary	Change in innate immune activation of renal allograft from baseline		6, 12, and 24 months after the transplant	No