NCT04786067

Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• 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 identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy

Conditions

• Kidney Transplant Immunosuppression

Interventions

Type	Name	Description
DRUG	Belatacept	Patients will have tapering of their multi-drug immunosuppression, until Belatacept is the sole medication in their immunosuppression regimen. Belatacept will be administered as an infusion, as is routinely done clinically.

Timeline

• Start date: 2021-07-28
• Primary completion: 2025-07-10
• Completion: 2025-07-30
• First posted: 2021-03-08
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study