TruGraf® Long-term Clinical Outcomes Study
Purpose
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.
Condition
- Kidney Transplant Rejection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Patients monitored with TruGraf and TRAC testing | 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. |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Unknown status
- Sponsor
- Transplant Genomics, Inc.
Detailed Description
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.