Study of OmniGraft in Simultaneous Pancreas Kidney Recipients (NCT06463873) | Clinical Trial Compass
TerminatedNot Applicable
Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
Stopped: The sponsor suspended the financial support.
United States40 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. Adults able to consent
✓. Bladder or enteric drained
✓. Type 1 or Type 2 DM
Exclusion criteria
✕. Recipient of an organ transplant other than a simultaneous pancreas kidney transplant
✕. Known to be pregnant
✕. Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus
✕. Active BK viremia with \>100,000 copies or biopsy proven BK nephropathy
✕. Participation in other biomarker studies
✕. Pancreas transplant alone
What they're measuring
1
Number of participants that underwent SPK transplant