Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

NCT06463873 | Terminated

• 1 other identifier: 20221147
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant; Complications; Pancreas Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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 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 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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Re-transplantation, unless both organs have been removed prior to or at the time of the retransplant procedure.

Sponsors & Collaborators

• University of Miami: lead
• Eurofins Lancaster Laboratories: collaborator

Study Sites (2)

Miami Transplant Institute 1801 NW 9th Ave

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Mariella Ortigosa-Goggins, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)