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The TOGETHER Project - Kidney RNA-seq Validation

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03874299
Collaborator
(none)
300
Enrollment
3
Locations
93.5
Anticipated Duration (Months)
100
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The researchers are trying to develop a way to measure the risk of rejection through the validation of a blood test.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients-RNA-seq Signature Validation
    Actual Study Start Date :
    Nov 17, 2016
    Actual Primary Completion Date :
    May 1, 2018
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Kidney Transplant Receipients

    Outcome Measures

    Primary Outcome Measures

    1. To validate the use of a RNA-seq based peripheral blood assay in renal transplant recipients. [3 years]

      The study will validate the ability of a peripheral blood assay to assess the risk of biopsy proven rejection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult (>/=18 years) renal transplant recipient.

    • Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.

    Exclusion Criteria:

    -Adult (<18 years) renal transplant recipient.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Scottsdale Arizona United States
    2 Mayo Clinic Jacksonville Florida United States
    3 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mark Stegall, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03874299
    Other Study ID Numbers:
    • 16-004433
    First Posted:
    Mar 14, 2019
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 5, 2022