This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring.
Approximately 15 U.S. sites
Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.
At least 18 years of age at the time of screening.
Enrollment begins 30 days prior to transplant till day 29 post-transplantation.
Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.
History of dual or en-bloc kidney transplants.
Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.
Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.
History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.
Study population- Post kidney transplant subjects 18 and older at leas 30 days post surgery will undergo TruGraf, TRAC and TRAC-ID biomarker testing at Mo 1,4,7,10,12,16,20 and 24.
Other
Other
There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
Diagnostic testInvestigators will prospectively record whether each results led to a change in clinical management. Participating sites will be encouraged to follow their usual practice, supplemented where appropriate by the suggested TruGraf and TRAC™ TRAC ID algorithms
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring
The primary endpoint is a composite at 24-months post-transplant, defined as the occurrence of any of the following events: • Biopsy-proven acute rejection (BPAR) on any for-cause biopsy between Month 1 to Month 24 (local read). OR • De novo Class I or Class II DSA detected at Month 12 or Month 24 (centrally read). OR • Decline in eGFR ≥20% from Month 3 to Month 24, calculated using the CKD-EPI creatinine-based equation. OR • Three or more abnormal TruGraf and TRAC results between Months 1 and 24
To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.
Actions taken based on tests results TruGraf, TRAC/TRAC-ID
To asses the safety of a double negative TruGraf/TRAC result
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
To explore the impact of biomarker -informed clinical decision-making on outcomes such as BPAR, estimated glomerular filtration rate (eGFR) trajectory, and immunosuppressive adjustments
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Exploratory objective: Evaluate the utility of serial TRAC-ID assays to monitor viral or systemic infections and guide safe adjustments of immunosuppression
TRAC-ID results will be available for Investigators
Click on the lead sponsor to view all of their trials.
Transplant Genomics, Inc.
Lead sponsor
Medical University of South Carolina
Collaborator
Northwestern University
Collaborator
The Cleveland Clinic
Collaborator
University of Washington
Collaborator
University of California, Los Angeles
Collaborator
University of Nebraska
Collaborator
Duke University
Collaborator
University of Utah
Collaborator
Georgetown University
Collaborator
Virginia Commonwealth University
Collaborator
The Methodist Hospital Research Institute
Collaborator
Keck School of Medicine USC
Collaborator
Weill Medical College of Cornell University
Collaborator
Erie County Medical Center
Collaborator
East Carolina University
Collaborator
AdventHealth
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
