Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Transplant Genomics

Status: Terminated

Conditions: Kidney Transplant Rejection

Treatments: Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04267016

TGRP01-US001

Details and patient eligibility

About

This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 >90 days (+/- 2 weeks) post-transplant will be included in this study

Exclusion criteria

• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients of previous non-renal solid organ and/or islet cell transplantation.
• Infection with HIV.
• Infection with BK nephropathy.
• Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Trial design

26 participants in 1 patient group

All Subjects Enrolled

Description:

Renal transplant recipients who are undergoing routine management

Treatment:

Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling