Status:
COMPLETED
Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
CareDx
Conditions:
Pancreas Transplant Rejection
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pi...
Detailed Description
This is a prospective and retrospective cohort study of recipients of simultaneous pancreas and kidney transplant recipients (SPK). New SPK transplant recipients and previous SPK transplant recipient...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- New SPK transplant recipients
- SPK recipients from September 2012 with functioning kidney and pancreas, not on dialysis and/or insulin
Exclusion
- The participant may not enter the study if ANY of the following apply:
- Unwilling to participate in research study
- Recipients of other solid organ transplants apart from the SPK
- Recipients of pancreas and kidney allografts from separate donors
- Recipients with SLE
- Patients who have received a bone marrow transplant
- Recipients of a transplant form a monozygotic twin
- Patients who are pregnant
- Patients below the age of 18 years
- SPK recipient on insulin at enrolment
- SPK recipient on dialysis
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04130685
Start Date
January 15 2020
End Date
December 1 2022
Last Update
December 2 2022
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612