TruGraf® Long-term Clinical Outcomes Study
- Conditions
- Kidney Transplant Rejection
- Interventions
- Diagnostic Test: Patients monitored with TruGraf and TRAC testing
- Registration Number
- NCT04491552
- Lead Sponsor
- Transplant Genomics, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients monitored with TruGraf and TRAC testing 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Proteinuria Baseline to month 24 defined by a spot urine protein-creatinine ratio \> 0.5
TruGraf results Baseline to month 24 The proportion of TruGraf not-TX results
TRAC results Baseline to month 24 The proportion of TRAC results \> 0.69
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) Baseline to month 24 Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
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 Clinical Utility of TruGraf and TRAC in clinical decision making Baseline to month 24 Percent of total number of TruGraf results that the PI identified as having clinical utility
Proportion of subjects with death-censored graft loss Baseline to month 24 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
Proportion of subjects with graft loss Baseline to month 24 defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period
Percent subject death period Baseline to month 24 Subject death from any cause at any time
Subject survival Baseline to month 24 calculated from date of kidney transplantation until date of patient death
Estimated GFR Baseline to month 24 calculated using the MDRD 4-variable equation
Graft survival Baseline to month 24 calculated from the date of kidney transplantation until data of graft loss
Trial Locations
- Locations (36)
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Illinois-Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Banner University Medical Center Tucson
🇺🇸Tucson, Arizona, United States
Fresno Nephrology Medical Group
🇺🇸Fresno, California, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
House of Transplant and Cancer- Riverside Community Hospital
🇺🇸Riverside, California, United States
Willis-Knighton Medical Center
🇺🇸Shreveport, Louisiana, United States
Universtiy of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Renal and Transplant Associates of New England
🇺🇸Springfield, Massachusetts, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Primary Coordinator Coordinator
🇺🇸Saint Louis, Missouri, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Clinical Research Strategies
🇺🇸Houston, Texas, United States
Utah Kidney Research Institute
🇺🇸Salt Lake City, Utah, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Primary Coordinator
🇺🇸Seattle, Washington, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of California Davis
🇺🇸Sacramento, California, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
UR Medicine Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States