Precision Medicine Offers Belatacept Monotherapy (PROBE)
Precision Medicine Offers Belatacept Monotherapy (PROBE)
研究概览
详细说明
Patients on belatacept who fulfill the entry criteria will be screened to determine if they have a quiescent molecular immunologic profile with kSORT and uCRM. Patients who screen negative on all 2 tests will undergo stepwise withdrawal first of steroids then of MMF or mTor inhibitors. Prior to each withdrawal the 2 screening molecular tests will be performed and advancement to the next withdrawal phase will be performed if both are negative. Patients who are maintained on belatacept monotherapy with quiescent kSORT and uCRM and elevated kSPOT will be transitioned to q 8 weeks belatacept administration.
Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment.
Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors) will follow the design shown in the Study Schema. Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations.
研究类型
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Stable renal function with a GFR ≥ 35 ml/min
- No history of acute rejection
- A spot urine protein creatinine ratio of 0.5 or less
- No DSA
Entry: Biomarker criteria
- Blood kSORT and urine CRM tests that are quiescent at entry and following each drug withdrawal.
- A third biomarker KSPOT will be used to assess if any patients has achieved tolerance.
Eligibility for 8 week Belatacept Administration
- Trough levels of belatacept at 4 weeks of greater than 2 µg/ml
- Trough levels of belatacept at 8 weeks of equal or greater than 1 µg/ml
Exclusion Criteria:
- Patients with < eGFR (35 ml/min)
- History of rejection
- Protein/creatinine rate >0.5
- Presence of DSA
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Belatacept patients
Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment. Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors). Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations. |
The transition to belatacept monotherapy and possibly to q 8 weeks administration can be safely done by applying personalized (i.e.
precision) medicine.
This includes phenotypic analysis of lymphocyte subsets, a quiescent molecular profiling of blood and urine prior to drug withdrawal and immune monitoring with KSORT after stepwise withdrawal of steroids and antiproliferatives.
Furthermore, trough PK of belatacept will be measured for conversion to q 8 week therapy for discovering research purposes.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent patients converted to belatacept
大体时间：12 months
|
To determine the percent of patients that can be safely converted to belatacept monotherapy
|
12 months
|
|
Percent patients safely converted to q8 week administration
大体时间：12 months
|
2. To determine the percent of patients on belatacept monotherapy that can be safely converted to 8 week administration of belatacept
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Flavio Vincenti, MD、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Belatacept的临床试验
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Bristol-Myers Squibb完全的肾移植美国, 阿根廷, 德国, 意大利, 智利, 西班牙, 巴西, 瑞典, 比利时, 法国, 匈牙利, 澳大利亚, 南非, 奥地利, 加拿大, 英国, 波兰, 捷克语, 挪威
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Assistance Publique - Hôpitaux de ParisBristol-Myers Squibb完全的
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University of California, San FranciscoJuvenile Diabetes Research Foundation完全的
-
Nantes University Hospital尚未招聘