Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
- Conditions
- Kidney Transplant Immunosuppression
- Interventions
- Diagnostic Test: Allosure and TruGrafOther: Immunosuppression Taper
- Registration Number
- NCT06336863
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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."
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 24
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Immunosuppression Taper 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. Immunosuppression Taper Allosure and TruGraf 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. Multi-Drug Regimen Allosure and TruGraf Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.
- Primary Outcome Measures
Name Time Method Incidence of acute kidney graft rejection 12 months after informed consent Number of patients with biopsy-proven acute kidney graft rejection
Incidence of facilitation to Belatacept monotherapy 12 months after the first study visit Percentage of subjects successfully weaned to a Belatacept monotherapy
- Secondary Outcome Measures
Name Time Method Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean 12 months after informed consent 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.
Incidence of de-novo donor specific antibodies (dnDSA) 12 months after informed consent 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.
Patient Survival after Immunosuppression Wean 12 months after informed consent Number of patients who died
Incidence of Proteinuria after Immunosuppression Wean 12 months after informed consent Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.
Kidney Graft Failure after Immunosuppression Wean 12 months after informed consent Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant
Trial Locations
- Locations (1)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States