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Sponsor decision to cancel study
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| Name | Class |
|---|---|
| Duke University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects Enrolled | Renal transplant recipients who are undergoing routine management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruGraf Testing - Peripheral blood gene expression profiling | Diagnostic Test | 5 mL collection PAXgene blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility of TruGraf Results | Percent of total number of TruGraf results that the PI identified as having clinical utility | through study completion, an average of 6 months |
| 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. | through study completion, an average of 6 months |
| Feasibility of TruGraf Testing | Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.
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| Name | Affiliation | Role |
|---|---|---|
| Patty West-Thielke, PharmD | Transplant Genomics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30979456 | Background | 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. | |
| 30979457 |
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| Background |
| 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. |