Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of patients with acute kidney graft rejection
研究概览
简要总结
The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult (>18 years) recipients of a kidney-only transplant, including re-transplants
- •Non-HLA identical Living or Deceased Donor Grafts
- •Able to provide informed consent
- •Absence of donor specific antigens
- •Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
- •Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
- •Patients who underwent kidney transplantation at least 9 months prior to study entry
排除标准
- •Prior or concurrent non-kidney organ transplants
- •Presence of BK nephropathy in current graft
- •Recipient on any other investigational drug in the 12 weeks prior to inclusion
- •Patient with history of recent (<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •Significant hepatic impairment
- •Bilateral kidney transplantation
- •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
研究组 & 干预措施
Immunosuppression Taper
Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.
干预措施: Belatacept (Drug)
结局指标
主要结局
Number of patients with acute kidney graft rejection
时间窗: 12 months after the date of the first immunosuppression taper
Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper
Number of Patients With Acute Kidney Graft Rejection
时间窗: 12 months after the date of the first immunosuppression taper
Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper
次要结局
- Mean change in Estimated Glomerular Filtration Rate (eGFR)(Baseline, 12 months after the start of immunosuppression wean)
- Number of patients with kidney graft failure(12 months after the start of immunosuppression wean)
- Number of patients who died(12 months after the start of immunosuppression wean, up to 36 months)
- Number of participants with Proteinuria(12 months after the start of immunosuppression wean)
- Number of participants with appearance of de-novo donor specific antibodies (dnDSA)(12 months after the start of immunosuppression wean)
- Negative predictable value as measured by AlloMap®(12 months after the start of immunosuppression wean)
- Mean prediction score of allograft loss as measured by iBox(12 months after the start of immunosuppression wean)
- Number of Patients Who Died(12 months after the start of immunosuppression wean)
- Number of Patients With Kidney Graft Failure(12 months after the start of immunosuppression wean)
- Mean Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline, 12 months after the start of immunosuppression wean)
- Number of Participants With Proteinuria(12 months after the start of immunosuppression weaning)
- Number of Participants With Appearance of De-novo Donor Specific Antibodies (dnDSA)(12 months after the start of immunosuppression wean)
- AlloMap® Level(12 months after the start of immunosuppression wean)
- Mean Prediction Score of Allograft Loss as Measured by iBox(12 months after the start of immunosuppression wean)
研究者
David Wojciechowski
Medical Director of the Kidney Transplantation Program
University of Texas Southwestern Medical Center