TruGraf® Testing in High-Risk Kidney Transplant Recipients

Stopped early

Conditions studied: Kidney Transplant Rejection

In brief

This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Key facts

Study ID

NCT04266613

Run by

Transplant Genomics, Inc.

People needed

19

Starts

2020-02-20

Expected to finish

2021-06-23

Last updated by the study team

2021-09-01

Who can join

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

You may qualify if…

• High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody >75%.
• Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
• Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels).
• Kidney transplant patients who are at least 30 days post-transplant.

You may not qualify if…

• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients who do not meet criteria of high-immune risk.
• Recipients of previous non-renal solid organ and/or islet cell transplantation.
• Infection with HIV.
• Infection with BK.
• Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Where it is running

• Houston Methodist Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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