NCT01914354

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

January 19, 2012

Last Update Submit

October 26, 2016

Conditions

Kidney Transplant

Keywords

T cellsHuman Alloimmune Reactivityimmunosuppression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • human kidney transplant recipients
  • ATG or basiliximab induction therapy

You may not qualify if:

  • induction therapy other than ATG or basiliximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood/serum

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

August 2, 2013

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

October 28, 2016

Record last verified: 2016-10