A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

Kidney Transplant; Complications Clinical Trial

Official title:

A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463873
• Other study ID #: 20221147
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: July 17, 2027

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Mariella Ortigosa-Goggins, MD
• Phone: 3053555111
• Email: mxo386[@]miami.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 17, 2027
• Est. primary completion date: July 17, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

4. Known to have active Polyoma (BK) nephropathy

5. Participation in other biomarker studies

Related Conditions & MeSH terms

• Kidney Transplant; Complications
• Pancreas Disease
• Pancreatic Diseases

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Eurofins Lancaster Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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