TruGraf® Long-term Clinical Outcomes Study

Study Overview
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Brief Summary
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This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Detailed Description
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Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion. Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.

Official Title
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TruGraf® Long-term Clinical Outcomes Study

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Diagnostic Test: Patients monitored with TruGraf and TRAC testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and HIPAA authorization; At least 18 years of age; Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant; At least 3-months post-transplant; Stable serum creatinine (per Principal Investigator); Treated with any immunosuppressive regimen, and; Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and Exclusion Criteria: Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant; Recipient of a previous non-renal solid organ and/or islet cell transplant; Known to be pregnant; Known to be infected with HIV; Known to have Active BK nephropathy; Known to have nephrotic proteinuria (Per Principal Investigator); Participation in other biomarker studies testing clinical utility.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients monitored with TruGraf and TRAC testing<br>Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection. | Diagnostic Test: Patients monitored with TruGraf and TRAC testing<br>* This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min. |  | Baseline to month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First occurrence of biopsy proven acute rejection (on a for cause biopsy) |  | Baseline to month 24 | 
| First occurrence of clinically treated acute rejection |  | Baseline to month 24 | 
| Proteinuria | defined by a spot urine protein-creatinine ratio > 0.5 | Baseline to month 24 | 
| TruGraf results | The proportion of TruGraf not-TX results | Baseline to month 24 | 
| TRAC results | The proportion of TRAC results > 0.69 | Baseline to month 24 | 
| Clinical Utility of TruGraf and TRAC in clinical decision making | Percent of total number of TruGraf results that the PI identified as having clinical utility | Baseline to month 24 | 
| Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) | Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) | Baseline to month 24 | 
| Proportion of subjects with graft loss | defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period | Baseline to month 24 | 
| Graft survival | calculated from the date of kidney transplantation until data of graft loss | Baseline to month 24 | 
| Proportion of subjects with death-censored graft loss | defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored | Baseline to month 24 | 
| Percent subject death period | Subject death from any cause at any time | Baseline to month 24 | 
| Subject survival | calculated from date of kidney transplantation until date of patient death | Baseline to month 24 | 
| Estimated GFR | calculated using the MDRD 4-variable equation | Baseline to month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Subclinical Rejection