Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
NCT ID: NCT04267016
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
26 participants
OBSERVATIONAL
2020-08-19
2021-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Subjects Enrolled
Renal transplant recipients who are undergoing routine management
TruGraf Testing - Peripheral blood gene expression profiling
5 mL collection PAXgene blood sample
Interventions
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TruGraf Testing - Peripheral blood gene expression profiling
5 mL collection PAXgene blood sample
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Transplant Genomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patty West-Thielke, PharmD
Role: STUDY_DIRECTOR
Transplant Genomics, Inc.
Locations
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Duke University
Durham, North Carolina, United States
Countries
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References
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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.
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.
Other Identifiers
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TGRP01-US001
Identifier Type: -
Identifier Source: org_study_id
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