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COMPLETED
NCT04786067
PHASE4

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2021-07-28

Completion Date

2025-07-30

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

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.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States