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OpenTrials
Completed

NCT Number: NCT03873623

The TOGETHER Project - Kidney

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.

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Key information

Conditions

Kidney Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring

Acronym: TOGETHER

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2019
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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