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The TOGETHER Project - Kidney (TOGETHER)

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ClinicalTrials.gov Identifier: NCT03873623
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

Study Description
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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.

Condition or disease
Kidney Transplant Rejection

Study Design
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Study Type : Observational
Actual 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 : December 1, 2022
Estimated Study Completion Date : December 1, 2023

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Groups and Cohorts
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Group/Cohort
Kidney Transplant Recipients


Outcome Measures
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Primary Outcome Measures :
  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 . [ 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
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.

Eligibility Criteria
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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
Study Population
Kidney transplant recipients.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Stegall, MD Mayo Clinic
More Information
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Responsible Party: Mark Stegall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03873623    
Other Study ID Numbers: 16-003159
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Stegall, Mayo Clinic:
Kidney transplant