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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Kidney Transplant Rejection

Clinical Trial Details

NCT number	NCT05482100
Study type	Observational
Source	Transplant Genomics, Inc.
Contact	Isioma Agboli, MD
Phone	15107678609
Email	isiomaagboli@eurofins-tgi.com
Status	Not yet recruiting
Phase
Start date	September 2022
Completion date	June 1, 2026

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT06243289` - Improving KIdney Transplantation With Cellular Therapy Study
Not yet recruiting	`NCT06025240` - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed	`NCT04367610` - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Enrolling by invitation	`NCT06126380` - Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients	Phase 2
Terminated	`NCT05747053` - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Active, not recruiting	`NCT03714113` - Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients	N/A
Recruiting	`NCT04091984` - The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Recruiting	`NCT05335538` - TruGraf and TRAC In Pediatrics Study
Completed	`NCT03663335` - Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients	Phase 2
Completed	`NCT03652402` - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting	`NCT04773392` - Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR	Phase 4
Completed	`NCT03873623` - The TOGETHER Project - Kidney
Terminated	`NCT02974686` - Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation	Phase 4
Terminated	`NCT04156204` - Immunosuppressant Medication Dosed Daily After Kidney Transplant	Early Phase 1
Completed	`NCT04601155` - Transition of Renal Patients Using AlloSure Into Community Kidney Care
Completed	`NCT03874299` - The TOGETHER Project - Kidney RNA-seq Validation
Completed	`NCT03965559` - The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms