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"

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."

Study Overview

• Status: Enrolling by invitation
• Conditions: Kidney Transplant Immunosuppression
• Intervention / Treatment: Diagnostic test: Allosure and TruGraf; Other: Immunosuppression Taper

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completion of the parent study (STU-2020-1339)
• Able to provide informed consent
• Absence of donor specific antibodies
• Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)

Exclusion Criteria:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
• Significant hepatic impairment
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
• Proteinuria > 0.5 g/g creatinine on spot urine sample within 3 months of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunosuppression Taper; Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	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.
Other: Multi-Drug Regimen; Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.	Diagnostic test: Allosure and TruGraf; Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute kidney graft rejection	Number of patients with biopsy-proven acute kidney graft rejection	12 months after informed consent
Incidence of facilitation to Belatacept monotherapy	Percentage of subjects successfully weaned to a Belatacept monotherapy	12 months after the first study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival after Immunosuppression Wean	Number of patients who died	12 months after informed consent
Kidney Graft Failure after Immunosuppression Wean	Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant	12 months after informed consent
Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean	Estimated glomerular filtration rate (eGFR) in blood will be measured at the beginning of enrollment and the difference will be measured to the end of the study as a measure of change in kidney function.	12 months after informed consent
Incidence of Proteinuria after Immunosuppression Wean	Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.	12 months after informed consent
Incidence of de-novo donor specific antibodies (dnDSA)	HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA) in those who have started the immunosuppression wean.	12 months after informed consent

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: David Wojciechowski, DO, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Immunosuppression; Weaning; Gene Expression; DNA Testing; Kidney Transplant Recipients; Belatacept Monotherapy
• Other Study ID Numbers: STU-2023-1151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes