Clinical trial NCT04267016: Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
Official title: A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplant Rejection
Lead sponsor: Transplant Genomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2020-02-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Clinical Utility of TruGraf Results
timeFrame: through study completion, an average of 6 months
measure: Correlation of TruGraf Results
timeFrame: through study completion, an average of 6 months
measure: Feasibility of TruGraf Testing
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Transplant Genomics, Inc.
name: Patty West-Thielke, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.