TruGraf® Testing in High-Risk Kidney Transplant Recipients

Transplant Genomics

Status: Terminated

Conditions: Kidney Transplant Rejection

Treatments: Diagnostic Test: TruGraf® Testing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04266613

TGRP03-US003

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

19 participants in 1 patient group

All Subjects Enrolled

Description:

High immune risk transplant recipients who are undergoing routine management under current standard of care

Treatment:

Diagnostic Test: TruGraf® Testing