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

NCT06336863 | Enrolling By Invitation FDA Device

• 1 other identifier: STU-2023-1151
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Belatacept Monotherapy; Kidney Transplant Recipients; Immunosuppression; Weaning; DNA Testing; Gene Expression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient Survival after Immunosuppression Wean

  12 months after informed consent

• Kidney Graft Failure after Immunosuppression Wean

  12 months after informed consent

• Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean

  12 months after informed consent

• Incidence of Proteinuria after Immunosuppression Wean

  12 months after informed consent

• Incidence of de-novo donor specific antibodies (dnDSA)

  12 months after informed consent

Study Arms (2)

Immunosuppression Taper

EXPERIMENTAL

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; Other: Immunosuppression Taper

Multi-Drug Regimen

OTHER

Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.

Diagnostic Test: Allosure and TruGraf

Interventions

Allosure and TruGraf DIAGNOSTIC_TEST

Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.

Immunosuppression Taper; Multi-Drug Regimen

Immunosuppression Taper OTHER

An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.

Immunosuppression Taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• David Wojciechowski, DO

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)