TruGraf® Testing in High-Risk Kidney Transplant Recipients

Terminated

• Conditions: Kidney Transplant Rejection
• Interventions: Diagnostic Test: TruGraf® Testing

• Registration Number: NCT04266613
• Lead Sponsor: Transplant Genomics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Start: 2020-02-20
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects Enrolled	TruGraf® Testing	High immune risk transplant recipients who are undergoing routine management under current standard of care

Primary Outcome Measures

Name	Time	Method
Clinical Utility of TruGraf Results	1 year	Percent of total number of TruGraf results that the PI identified as having clinical utility
Correlation of TruGraf Results	1 year	Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care

Trial Locations

Locations (1)

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States