Role of CD28null NKG2Dpos T Cells on Human Alloimmune Reactivity T Cell Population (NKG2D)

October 26, 2016 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort of 80 living and deceased donor kidney transplant recipients and 10 healthy volunteers

Description

Inclusion Criteria:

  • human kidney transplant recipients
  • ATG or basiliximab induction therapy

Exclusion Criteria:

  • induction therapy other than ATG or basiliximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 859869783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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