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

Kidney Transplant Immunosuppression Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336863
• Other study ID #: STU-2023-1151
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: David Wojciechowski, DO
• Phone: 214-645-7846
• Email: David.Wojciechowski[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Immunosuppression

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney graft rejection	Number of patients with biopsy-proven acute kidney graft rejection	12 months after informed consent
Primary	Incidence of facilitation to Belatacept monotherapy	Percentage of subjects successfully weaned to a Belatacept monotherapy	12 months after the first study visit
Secondary	Patient Survival after Immunosuppression Wean	Number of patients who died	12 months after informed consent
Secondary	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
Secondary	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
Secondary	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
Secondary	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