The TOGETHER Project - Kidney
TOGETHER
The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring
1 other identifier
observational
250
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2019
CompletedFebruary 7, 2022
February 1, 2022
3.1 years
March 12, 2019
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
3 years
Study Arms (1)
Kidney Transplant Recipients
Eligibility Criteria
Kidney transplant recipients.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
7.5 ml of blood assays will be collected. Peripheral blood will be collected at 1, 4, 6, 9, and 12 months, as well as any for cause time points.
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Stegall, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 13, 2019
Study Start
November 1, 2016
Primary Completion
December 19, 2019
Study Completion
December 19, 2019
Last Updated
February 7, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share