TruGraf® Testing in High-Risk Kidney Transplant Recipients

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2021-06-23

Brief Summary

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This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. 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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Detailed Description

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Conditions

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Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Subjects Enrolled

High immune risk transplant recipients who are undergoing routine management under current standard of care

TruGraf® Testing

Intervention Type DIAGNOSTIC_TEST

5 mL collection PAXgene blood sample

Interventions

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TruGraf® Testing

5 mL collection PAXgene blood sample

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Peripheral blood gene expression profiling

Eligibility Criteria

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Inclusion Criteria

* High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody \>75%.
* 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 at least 30 days post-transplant.

Exclusion Criteria

* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
* Recipients who do not meet criteria of high-immune risk.
* Recipients of previous non-renal solid organ and/or islet cell transplantation.
* Infection with HIV.
* Infection with BK.
* Patients that have nephrotic proteinuria (urine protein \>3 gm/day).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No