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.
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