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The TOGETHER Project - Kidney (TOGETHER)

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ClinicalTrials.gov Identifier: NCT03873623
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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
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

Resource links provided by the National Library of Medicine


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 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      
Sponsors and Collaborators
Mayo Clinic
More Information
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Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

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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

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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