Immune Monitoring to Facilitate Belatacept Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence of Acute Rejection
研究概览
简要总结
- To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy.
- To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.
详细描述
This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age minimum 18 years
- •Written informed consent
- •Single kidney transplant recipient (i.e. no combined organ transplants)
- •Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
- •At least 1 year after transplantation or after initiation of belatacept
- •Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)
- •Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA < 1%; for Trugraf this corresponds to "TX" signature)
- •No history of BK viremia in current allograft
排除标准
- •History of biopsy-proven acute rejection
- •Presence of donor-specific antibodies (at any MFI)
- •Spot urine protein/creatinine ratio > 0.5 g/g
研究组 & 干预措施
Belatacept treated patients
Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone
干预措施: Allosure (Diagnostic Test)
Belatacept treated patients
Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone
干预措施: Immunosuppression reduction (Drug)
Belatacept treated patients
Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone
干预措施: Trugraf (Diagnostic Test)
结局指标
主要结局
Incidence of Acute Rejection
时间窗: Through study completion, 1 year
Biopsy-proven according to Banff 2017 criteria
次要结局
- Survival(At 12 months)
- Increase in eGFR(From baseline to 12 months)
- Rate of New-onset Proteinuria(At 12 months)
- Incidence of de Novo Donor Specific Antibodies(At 12 months)
研究者
Hannah Gilligan
Principal investigator
Massachusetts General Hospital