Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

Study Overview
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Brief Summary
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The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.

Detailed Description
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This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine <2.3 mg/dl, <20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (>24 months but < 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-transplant and are undergoing routine management. In Study A, patients will receive testing eight times: Month 2 (at time of surveillance biopsy) 6(at time of surveillance biopsy), 9, 12(at time of surveillance biopsy), 15, 18, 21 and 24(at time of surveillance biopsy) (plus or minus two weeks). Results of the genomic analysis will be considered in determining patient treatment plans and as a molecular guide to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. In Study B, patients who are at least 2 years post transplant up to 5 years post-transplant will receive testing 8 times: Months 3 ,6, 9, 12, 15, 18, 21 and 24 (plus or minus two weeks)from the time of enrollment into the study. Results of the genomic analysis will be considered in determining patient treatment plans and whether any change is needed, such as whether to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. We expect Study A to be completed 24-30months and Study B to be completed in 24-30 months.

Official Title
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Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Diagnostic Test: Diagnostic Test: TruGraf® Testing


Participation Criteria
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Eligibility Criteria
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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 are: > 60 days post-transplant (Cohort A); > 2-years post-transplant (Cohort B) 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. Patients that have nephritic proteinuria (urine protein >3 gm/day).

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 |
| --- | --- |
| Cohort A: Clinical Practice<br>Subjects more than 60 days post-transplant | Diagnostic Test: Diagnostic Test: TruGraf® Testing<br>* 5 mL collection PAXgene blood sample<br>* Other names: Peripheral blood gene expression profiling;|
| Cohort B: Long Term Follow-Up<br>Subjects who are at least 2 years post transplant up to 5 years post-transplant | Diagnostic Test: Diagnostic Test: TruGraf® Testing<br>* 5 mL collection PAXgene blood sample<br>* Other names: Peripheral blood gene expression profiling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results |  | 12 months post-transplant | 
| Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results |  | 24 months post-transplant | 
| Cohort A: Correlation of TruGraf test results with surveillance biopsy |  | 2 years | 
| Cohort A and B: Banff pathology | Banff pathology will be assessed and compared to TruGraf results. | 2 years | 
| Cohort A and B: Renal graft function | Renal graft function will be assessed by measuring Estimated Glomerular Filtration Rate (eGFR). | 2 years | 
| Cohort A and B: Renal graft function | Renal graft function will be assessed by measuring serum creatinine (sCr) levels. | 2 years | 
| Cohort A and B: Cost of patient care | The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death |  | 2 years | 
| Incidence of graft loss |  | 2 years |