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

Completed

• Conditions: Kidney Transplant

• Registration Number: NCT01914354
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-19
• Study Start: 2012-02
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• human kidney transplant recipients
• ATG or basiliximab induction therapy

Exclusion Criteria

• induction therapy other than ATG or basiliximab

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To document the prevalence and frequencies of CD4+ and CD8+ CD28null/NKG2Dpos T cells at the time of transplantation.	6 months
To test whether CD28null/NKG2Dpos T cells have unique rapid activation properties to allogeneic HLA antigens in vitro	6 months

Secondary Outcome Measures

Name	Time	Method
To study the clinical correlations between the frequencies of alloreactive CD28null/NKG2Dpos T cells with kidney graft function and histopathology.	6 months
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