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NCT01914354 Clinical Trial

Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity T Cell Population

Kidney Transplant Clinical Trial

— NKG2D  

Official title:
Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity: An Untargeted T Cell Population" (# 859869783).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01914354
Other study ID # 859869783
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated October 26, 2016
Start date February 2012
Est. completion date June 2014

Study information
Verified date October 2016
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This is an observational multi-center study to determine whether any single immune monitoring test or a combination of tests obtained in the first 6 months after renal transplantation correlates with acute rejection or graft loss in renal allograft recipients receiving commonly used immunosuppressive.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date June 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- human kidney transplant recipients

- ATG or basiliximab induction therapy

Exclusion Criteria:

- induction therapy other than ATG or basiliximab

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary To document the prevalence and frequencies of CD4+ and CD8+ CD28null/NKG2Dpos T cells at the time of transplantation. 6 months No
Primary To test whether CD28null/NKG2Dpos T cells have unique rapid activation properties to allogeneic HLA antigens in vitro 6 months No
Secondary To study the clinical correlations between the frequencies of alloreactive CD28null/NKG2Dpos T cells with kidney graft function and histopathology. 6 months No
Secondary To test the effects of induction therapy with rabbit anti-thymocyte globulin (ATG) vs. IL-2 receptor blocker antibodies on circulating CD28null/NKG2Dpos T cells. 6 months No
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