PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplan… (NCT07231328) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
600 participantsStarted 2025-11-20
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Receiving any immunosuppressive regimen.
* Able and willing to comply with all study procedures, as assessed by the Investigator.
* Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care
Exclusion Criteria:
History of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.
* 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.
*…
What they're measuring
1
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring