CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients

NCT ID: NCT05482100

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-06-01

Brief Summary

This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Detailed Description

The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Conditions

Kidney Transplant Rejection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients monitored with OmniGraf Testing

Subjects will have OmniGraf™ testing at study enrollment and thereafter every 3 months or at the same time as standard routine labs (minimum two per year). In addition, subjects will have OmniGraf™ testing at any time there is a workup for clinical events and referral to advanced care (transplant center, biopsy, etc)

Patients monitored with OmniGraf testing

Intervention Type: DIAGNOSTIC_TEST

This is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management.

Interventions

Patients monitored with OmniGraf testing

This is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Written informed consent and HIPAA authorization;
• At least 18 years of age;
• Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
• Between 3 months and 2 years post-transplant;
• Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care

Exclusion Criteria

• Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
• Recipient of a previous non-renal solid organ and/or islet cell transplant;
• Known to be pregnant;
• Known to be infected with Human Immunodeficiency Virus (HIV);
• Known to have active BK nephropathy;
• Known to have nephrotic proteinuria (per principal investigator); or
• Participation in other biomarker studies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Transplant Genomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patty West-Thielke, PharmD

Role: STUDY_DIRECTOR

Transplant Genomics

Central Contacts

Isioma Agboli, MD

Role: CONTACT

isiomaagboli@eurofins-tgi.com

15107678609

James Fleming, PharmD

Role: CONTACT

JamesFleming@eurofins-tgi.com

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Other Identifiers

TGRP11

Identifier Type: -

Identifier Source: org_study_id