The TOGETHER Project - Kidney
Completed
- Conditions
- Kidney Transplant Rejection
- Registration Number
- NCT03873623
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 . 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States