评估 Alefacept 在新肾移植受者中的安全性和有效性的初步研究
2013年5月1日 更新者：M. Javeed Ansari、Northwestern University
本研究的目的是评估 Alefacept 联合阿仑单抗诱导和钙调神经磷酸酶抑制剂以及皮质类固醇戒断。
研究概览
详细说明
这是一项由研究者发起的单中心试点研究，旨在评估 Alefacept 联合 Alemtuzumab 诱导和 Myfortic 与快速类固醇和神经钙蛋白抑制剂撤药在新肾移植受者中的安全性和有效性。
诱导治疗包括围手术期单剂量阿仑单抗和类固醇。
他克莫司将在移植后的前 30 天内给药。 Alefacept 将在前两个剂量中静脉内给药，然后每周皮下注射直至移植后 12 周，然后在研究的剩余时间内每月注射一次。
主要结果是安全性和有效性结果，包括活检证实的急性排斥事件、感染性并发症或其他严重不良事件。
次要结果包括通过免疫监测分析评估的 T 辅助细胞分化、细胞因子产生和 T 调节细胞生成。
研究类型
介入性
注册 (实际的)
9
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 机构审查委员会 (IRB) 批准了在研究相关程序（包括停用违禁药物（如适用）
- 从非 HLA 相同的相关活体供体、非相关活体供体或已故供体的肾脏接受者
- 从头开始肾移植的接受者
- ≥ 18 岁
- 预期在移植手术后 48 小时内接受首次口服他克莫司
- 有生育潜力的女性受试者的尿液或血清妊娠试验必须呈阴性，并且必须同意在研究期间保持有效的避孕措施
健康的捐献者有资格抽血，如果：
- 机构审查委员会 (IRB) 批准的书面知情同意书和健康保险流通与责任法案 (HIPAA) 对美国网站的授权，或根据国家法规的等效隐私语言，是在任何研究相关程序之前从受试者那里获得的
- 受试者是参与研究的新肾移植受试者的供体，或不是参与研究的受试者的肾脏供体的自我声明健康的志愿者
- ≥ 18 岁
排除标准：
- 以前接受过或正在接受肾脏以外的器官移植
- 对碘敏感
- 将接受来自非心脏跳动捐赠者的移植（心脏死亡后捐赠 - DCD）
- 从 HLA 相同的相关活体供体接受移植
- 将从年龄小于 5 岁的已故捐赠者那里获得一个单独的肾脏
- 将接受预计冷缺血时间 (CIT) > 30 小时的肾脏
- 将接受 ABO 血型不相容的供体肾脏
- 已知接受者或捐赠者对人类免疫缺陷病毒 (HIV) 呈血清反应阳性
- 根据研究中心的标准确定方法，接受者具有阳性 T 或 B 细胞交叉配型。 对于进行了流式细胞术交叉配型且在 T 细胞或 B 细胞检测中呈阳性的接受者，仅当通过基于流式细胞术的特异性抗 HLA 抗体检测检测到供体特异性抗 HLA 抗体时，才排除接受者。
- 当前的恶性肿瘤或恶性肿瘤病史（过去 5 年内），已成功治疗的非转移性基底细胞癌或鳞状细胞癌除外
- 严重的肝病
- 巨细胞病毒 (CMV) 血清学阴性且 CMV 供体血清学阳性
- Epstein Barr 病毒血清学阴性
- 在研究药物首次给药前的三个月内接受过静脉内免疫球蛋白 (IVIG) 治疗
- 不受控制的伴随感染或任何其他可能干扰研究目标的不稳定医疗状况
- 同时参加另一项药物研究或在移植前 28 天内接受过研究药物
- 已知对阿法西普、阿仑单抗、他克莫司、麦考酚酸、皮质类固醇或其任何成分过敏
- 任何形式的药物滥用、精神障碍或研究者认为可能使与研究者的沟通无效的情况
- 受试者怀孕或哺乳
- 受试者不太可能遵守协议中安排的访问
- 受试者将从扩大标准供体 (ECD) 接受肾移植
- 将从 CDC 高风险捐赠者那里接受肾脏移植
如果出现以下任何情况，健康供体受试者将被排除在参与之外：
- 无法理解协议参与的调查性质
- 全血细胞计数结果确定超出正常范围
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
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实验性的：阿法西普 (ASP0485)
Alefacept 联合阿仑单抗诱导和钙调磷酸酶抑制剂 (CNI) 以及皮质类固醇戒断的安全性和有效性。
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移植后 30 天停用钙调神经磷酸酶抑制剂。
给予 Alefacept 7.5 毫克术后第 0 天，术后第 2 天静脉注射； Alefacept 15 mg SQ X 12 周，然后每月一次，直到第 12 个月。
其他名称：
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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 |
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首次活检证实的急性排斥反应（Banff 等级≥ 1）（BCAR 率）和感染的发生率
大体时间：移植后 12 个月
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通过检查首次活检证实的急性排斥反应（Banff Grade≥1）（BCAR率）以及感染的发生率和临床表现。
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移植后 12 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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对免疫细胞的影响
大体时间：移植后长达 12 个月
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通过使用各种免疫监测分析，评估 alefacept 如何影响 T 细胞分化、记忆和免疫调节 T 细胞稳态、B 细胞和细胞因子/趋化因子概况。
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移植后长达 12 个月
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评估有效性和安全性的次要结果指标
大体时间：移植后长达 12 个月
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12 个月时：患者/移植物存活率、BCAR 率、BCAR 急性排斥反应的最高等级、临床治疗急性排斥反应的发生率、用于治疗排斥反应的抗淋巴细胞抗体治疗发生率、多次排斥反应发生率、治疗发生率失败（定义为死亡、移植物丢失、活组织检查确认的急性排斥反应、失访或提前停止治疗方案）、白细胞减少症的发生率、细菌、真菌、病毒或寄生虫感染的发生率。
在 6 个月和 12 个月时：血清肌酐，通过碘海醇清除率测定的 GFR。
第一次 BCAR 的时间
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移植后长达 12 个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：M. Javeed Ansari, MD、Northwestern Universiy, Northwestern Memorial Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年7月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2010年7月14日
首先提交符合 QC 标准的
2010年7月15日
首次发布 (估计)
2010年7月16日
研究记录更新
最后更新发布 (估计)
2013年5月3日
上次提交的符合 QC 标准的更新
2013年5月1日
最后验证
2013年5月1日
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.
阿法西普 (ASP0485)的临床试验
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Astellas Pharma IncAstellas Pharma Canada, Inc.终止
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Astellas Pharma IncAstellas Pharma Canada, Inc.完全的
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Astellas Pharma IncBiogen完全的
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Astellas Pharma IncBiogen完全的
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Massachusetts General HospitalBrigham and Women's Hospital; Stanford University; Biogen终止
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Astellas Pharma IncBiogen完全的