Kidney Transplant; Complications, Pancreas Disease
Conditions
Brief summary
The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.
Interventions
None listed
Sponsors
Eurofins Lancaster Laboratories
University of Miami
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adult (≥18 years old) with a history of simultaneous pancreas kidney transplant between 3 months and 1 year prior to enrollment (cohort 1) or at the time of presentation for for-cause biopsy 2. Adults able to consent 3. Bladder or enteric drained 4. Type 1 or Type 2 DM
Exclusion criteria
1. Recipient of an organ transplant other than a simultaneous pancreas kidney transplant 2. Known to be pregnant 3. Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus 4. Active BK viremia with \>100,000 copies or biopsy proven BK nephropathy 5. Participation in other biomarker studies 6. Pancreas transplant alone 7. Re-transplantation, unless both organs have been removed prior to or at the time of the retransplant procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that underwent SPK transplant | Up to 3 years | Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA. |
Countries
United States
Outcome results
None listed