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

Terminated

• Conditions: Kidney Transplant Rejection
• Interventions: Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling

• Registration Number: NCT04267016
• Lead Sponsor: Transplant Genomics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Start: 2020-08-19
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Subjects Enrolled	TruGraf Testing - Peripheral blood gene expression profiling	Renal transplant recipients who are undergoing routine management

Primary Outcome Measures

Name	Time	Method
Feasibility of TruGraf Testing	through study completion, an average of 6 months	Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow
Clinical Utility of TruGraf Results	through study completion, an average of 6 months	Percent of total number of TruGraf results that the PI identified as having clinical utility
Correlation of TruGraf Results	through study completion, an average of 6 months	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)

Duke University; 🇺🇸 Durham, North Carolina, United States