Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
NCT ID: NCT06336863
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
24 participants
INTERVENTIONAL
2024-06-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Allosure and TruGraf
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
Immunosuppression Taper
An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.
Multi-Drug Regimen
Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.
Allosure and TruGraf
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
Interventions
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Allosure and TruGraf
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
Immunosuppression Taper
An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Absence of donor specific antibodies
* Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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David Wojciechowski
Associate Professor, Internal Medicine
Principal Investigators
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David Wojciechowski, DO
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU-2023-1151
Identifier Type: -
Identifier Source: org_study_id
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