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TerminatedNCT04267016Updated Sep 28, 2021

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

An observational study in Kidney Transplant Rejection, sponsored by Transplant Genomics, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Transplant Genomics, Inc. · Observational

Why this study was terminated
Sponsor decision to cancel study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Kidney Transplant Rejection
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In context

Lead sponsor

Transplant Genomics, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • All Subjects Enrolled

    Renal transplant recipients who are undergoing routine management

    Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling

Interventions

  • Diagnostic testTruGraf Testing - Peripheral blood gene expression profiling

    5 mL collection PAXgene blood sample

    Also known as: Standard of care

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What researchers measure

Primary outcomes

  1. Clinical Utility of TruGraf Results

    Percent of total number of TruGraf results that the PI identified as having clinical utility

    Time frame: through study completion, an average of 6 months

  2. Correlation of TruGraf Results

    Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care.

    Time frame: through study completion, an average of 6 months

  3. Feasibility of TruGraf Testing

    Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow

    Time frame: through study completion, an average of 6 months

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Study locations

1 site
  • Duke University
    Durham, North Carolina 27710, United States
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References and documents

Publications

  • Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26. PubMed 30979456 ↗
  • First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11. PubMed 30979457 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04267016
Lead sponsor
Transplant Genomics, Inc.
Collaborators
Duke University
Responsible party
Sponsor
First posted
Feb 12, 2020
Start date
Aug 19, 2020
Primary completion
May 11, 2021
Completion
May 11, 2021
Last update
Sep 28, 2021

Study contacts

Patty West-Thielke, PharmD
study director · Transplant Genomics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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