Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

University of Miami

Status: Terminated

Conditions: Pancreas Disease; Kidney Transplant; Complications

Study type: Observational

Funder types: Other

Identifiers

NCT06463873

20221147

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

Omnigraft 3 month - 1 year Group 1

Description:

Subjects will be enrolled between 2 months and 1 year post Simultaneous Pancreas Kidney (SPK) transplant. Blood sample to test Omnigraft will be collected monthly month or every 3 months depending on the enrollment time, time of rejection, or when a biopsy is done.

Omnigraft 1 year - 3 years Group 2

Description:

Subjects will be enrolled between 12 months and 3 year post SPK transplant. Blood sample to test Omnigraft will be collected every 3 months, at the time of rejection or when a biopsy is done.

Omnigraft 10 years Group 3

Description:

Subjects will be enrolled between 3 years to 10 years post SPK transplant. Then, blood samples to test Omnigraft will be collected every 3 months, time of rejection or when a biopsy is done.