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

The University of Texas System (UT)

Status: Invitation-only

Conditions: Kidney Transplant Immunosuppression

Treatments: Other: Immunosuppression Taper; Diagnostic Test: Allosure and TruGraf

Study type: Interventional

Funder types: Other

Identifiers

NCT06336863

STU-2023-1151

Details and patient eligibility

About

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."

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Immunosuppression Taper

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Allosure and TruGraf

Other: Immunosuppression Taper

Multi-Drug Regimen

Other group

Description:

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

Treatment:

Diagnostic Test: Allosure and TruGraf