A Study of Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients with Realtime Assay Monitoring

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-003159
    • Jacksonville, Florida: 16-003159
    • Rochester, Minnesota: 16-003159
    Sponsor Protocol Number: 16-003159

About this study

The purpose of this study is to connect the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in kidney transplants) with rejection episodes in kidney transplant patients that are managed using standard of care clinical protocols at the three Mayo transplant sites. 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Adult ≥ 18 years
  • A conventional solitary kidney transplant recipient (ABO compatible, crossmatch negative, not a kidney transplant simultaneously transplanted with another non-renal organ including heart, liver, lung or pancreas) who receives from a living or deceased donor
  • Has given informed consent and is willing and able to undergo peripheral blood collection at the specified time points and willing to participate in follow-up

Exclusion Criteria

  • Multiorgan transplant (ex.SLK, SPK) or prior recipient of non-renal transplant
  • EBV seronegative recipients
  • 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
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

Contact information:

Samantha Parker

(480)342-6677

Parker.Samantha@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

Contact information:

Joel Espinoza

(904)953-8855

Espinoza.Joel@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

Contact information:

Jordan Scheevel

Scheevel.Jordan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20358451

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