The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring

Mayo Clinic1 site in 1 country250 target enrollmentNovember 2016

ConditionsKidney Transplant Rejection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Transplant Rejection
Sponsor: Mayo Clinic
Enrollment: 250
Locations: 1
Primary Endpoint: To correlate the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in renal allografts) with rejection episodes in renal transplant patients .
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Researchers are trying to develop a way to customize immunosuppression treatment, based on the results of a blood test that measures the risk of rejection.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

December 19, 2019

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Mark Stegall

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Conventional solitary kidney transplant (ABO compatible, crossmatch negative, not a kidney transplant simultaneously transplanted with another non-renal organ including heart, liver, lung or pancreas)
•Patients who have given informed consent and are willing to comply with the protocol, including the use of their specimens and data for subsequent research.

Exclusion Criteria

•EBV -seronegative recipient
•ABO incompatible kidney transplants.
•Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, bone marrow transplantation, etc or prior recipient of non-renal transplant. Subjects who had previous extra renal transplants may be included in the study.
•Positive crossmatch kidney transplants (T cell crossmatch \>100, B flow cytometric crossmatch \>150).
•Participating in other clinical trials
•Any kidney transplant recipient \< 18 years of age.

Outcomes

Primary Outcomes

To correlate the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in renal allografts) with rejection episodes in renal transplant patients .

Time Frame: 3 years

The study will validate the ability of a peripheral blood assay to assess the risk of rejection and determine the role this assay will have in immunosuppression monitoring in our patients at Mayo Clinic (3 sites).