The TOGETHER Project - Kidney (TOGETHER)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03873623 |
Recruitment Status :
Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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Condition or disease |
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Kidney Transplant Rejection |
Study Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring |
Actual Study Start Date : | November 2016 |
Estimated Primary Completion Date : | February 2020 |
Estimated Study Completion Date : | April 2020 |

Group/Cohort |
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Kidney Transplant Recipients |
- 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).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873623
United States, Arizona | |
Mayo Clinic | Recruiting |
Scottsdale, Arizona, United States | |
Contact: Samantha Parker 480-342-6677 | |
United States, Florida | |
Mayo Clinic | Recruiting |
Jacksonville, Florida, United States | |
Contact: Joel Espinoza 904-953-2865 | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Leah Majerus 507-255-3940 |
Additional Information:
Responsible Party: | Mark Stegall, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03873623 History of Changes |
Other Study ID Numbers: |
16-003159 |
First Posted: | March 13, 2019 Key Record Dates |
Last Update Posted: | March 13, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney transplant |