NCT06336863

Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

An Extension Protocol for Subjects Previously Enrolled in the "Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients"

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."

Conditions

• Kidney Transplant Immunosuppression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Allosure and TruGraf	Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
OTHER	Immunosuppression Taper	An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-03-29
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study