The TOGETHER Project - Kidney

Mayo Clinic250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Kidney Transplant Rejection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Mayo Clinic

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

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 .

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).

Time frame: 3 years

Data from ClinicalTrials.gov

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