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

N/AEnrolling By InvitationNCT06336863

University of Texas Southwestern Medical Center24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplant Immunosuppression

Interventions

Allosure and TruGrafDIAGNOSTIC_TEST

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

Immunosuppression TaperOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Incidence of acute kidney graft rejection

Number of patients with biopsy-proven acute kidney graft rejection

Time frame: 12 months after informed consent

Incidence of facilitation to Belatacept monotherapy

Percentage of subjects successfully weaned to a Belatacept monotherapy

Time frame: 12 months after the first study visit

Secondary Outcomes

Patient Survival after Immunosuppression Wean

Number of patients who died

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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