Serial Blood and Urine Monitoring Study in Kidney Transplant Recipients

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: 09-007577
    NCT ID: NCT01289717
    Sponsor Protocol Number: CTOT-08

About this study

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

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:

  • Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
  • Subject and/or parent guardian must be able to understand and provide informed consent.
  • Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry.

Exclusion Criteria:

  • Need for combined organ transplantation with an extra-renal organ and/or islet.
  • Recipient of previous non-renal solid organ and/or islet cell transplantation.
  • Infection with HCV or HIV.
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

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

Raymond Heilman, M.D.

Closed for enrollment

Contact information:

Michael Leonard CCRP

(480)342-2908

Leonard.Michael@mayo.edu