TruGraf® Long-term Clinical Outcomes Study

Status unconfirmed

Conditions studied: Kidney Transplant Rejection

In brief

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Key facts

Study ID

NCT04491552

Run by

Transplant Genomics, Inc.

People needed

2000

Starts

2020-09-09

Expected to finish

2023-11-01

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent and HIPAA authorization;
• At least 18 years of age;
• Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
• At least 3-months post-transplant;
• Stable serum creatinine (per Principal Investigator);
• Treated with any immunosuppressive regimen, and;
• Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and

You may not qualify if…

• Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
• Recipient of a previous non-renal solid organ and/or islet cell transplant;
• Known to be pregnant;
• Known to be infected with HIV;
• Known to have Active BK nephropathy;
• Known to have nephrotic proteinuria (Per Principal Investigator);
• Participation in other biomarker studies testing clinical utility.

Where it is running

• Banner University Medical Center Tucson — Tucson, Arizona, United States (enrolling)
• Fresno Nephrology Medical Group — Fresno, California, United States (enrolling)
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States (enrolling)
• Keck Hospital of USC — Los Angeles, California, United States (enrolling)
• House of Transplant and Cancer- Riverside Community Hospital — Riverside, California, United States (enrolling)
• University of California Davis — Sacramento, California, United States (enrolling)
• California Pacific Medical Center — San Francisco, California, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois-Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States (enrolling)
• Willis-Knighton Medical Center — Shreveport, Louisiana, United States (enrolling)
• Universtiy of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Renal and Transplant Associates of New England — Springfield, Massachusetts, United States (enrolling)
• Primary Coordinator Coordinator — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (enrolling)
• Erie County Medical Center — Buffalo, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• UR Medicine Strong Memorial Hospital — Rochester, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Vidant Medical Center — Greenville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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