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"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney graft rejection
研究概览
简要总结
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."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Allosure and TruGraf (Diagnostic Test)
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.
干预措施: Immunosuppression Taper (Other)
Multi-Drug Regimen
Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.
干预措施: Allosure and TruGraf (Diagnostic Test)
结局指标
主要结局
Incidence of acute kidney graft rejection
时间窗: 12 months after informed consent
Number of patients with biopsy-proven acute kidney graft rejection
Incidence of facilitation to Belatacept monotherapy
时间窗: 12 months after the first study visit
Percentage of subjects successfully weaned to a Belatacept monotherapy
次要结局
- Kidney Graft Failure after Immunosuppression Wean(12 months after informed consent)
- Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean(12 months after informed consent)
- Incidence of de-novo donor specific antibodies (dnDSA)(12 months after informed consent)
- Patient Survival after Immunosuppression Wean(12 months after informed consent)
- Incidence of Proteinuria after Immunosuppression Wean(12 months after informed consent)
研究者
David Wojciechowski
Associate Professor, Internal Medicine
University of Texas Southwestern Medical Center