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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

Tracking Information
First Submitted Date March 12, 2019
First Posted Date March 13, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date November 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2019)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The TOGETHER Project - Kidney
Official Title The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Probability Sample
Study Population Kidney transplant recipients.
Condition Kidney Transplant Rejection
Intervention Not Provided
Study Groups/Cohorts Kidney Transplant Recipients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 12, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03873623
Other Study ID Numbers 16-003159
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mark Stegall, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account Mayo Clinic
Verification Date March 2019