Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

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.

Study Overview

• Status: Terminated
• Conditions: Pancreas Disease; Kidney Transplant; Complications

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33136
      • Miami Transplant Institute 1801 NW 9th Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Simultaneous kidney pancreas transplant who are treated at the Miami Transplant Institute

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Omnigraft 1 year - 3 years Group 2; 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 3 month - 1 year Group 1; 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 10 years Group 3; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that underwent SPK transplant	Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA.	Up to 3 years

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Eurofins Lancaster Laboratories
• Investigators: Principal Investigator: Mariella Ortigosa-Goggins, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 20221147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No