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

A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04267016

Enrollment

Registered

2020-02-12

Start date

2020-08-19

Completion date

2021-05-11

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection

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.

Interventions

DIAGNOSTIC_TESTTruGraf Testing - Peripheral blood gene expression profiling

5 mL collection PAXgene blood sample

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
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.
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026