Randomized Controlled Trial of ImmuKnow in Liver Transplantation
2013年1月7日 更新者：Matteo Ravaioli、University of Bologna
Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients
ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy.
Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression.
The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation.
This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events
研究概览
详细说明
We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values.
Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP.
Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP.
Immunosuppression of the Control group was managed by the Standard of Care at our institution.
ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.
研究类型
介入性
注册 (实际的)
206
阶段
- 不适用
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
18年 至 70年 (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
Inclusion Criteria:
- consecutive adult liver transplant recipients at our center;
- patients not entered into other studies;
- provided consent.
Exclusion Criteria:
- available follow-up;
- consent removed.
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tacrolimus dose regulation
Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL.
|
Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL.
Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP.
The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event
其他名称：
|
|
无干预：Control
immunosuppressive therapy is managed either by standard practice at our center (Control)
|
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 |
|---|---|---|
|
Comparison of adverse events
大体时间：12 months posttransplant
|
Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups
|
12 months posttransplant
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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
- 研究主任：Antonio Daniele Pinna, MD、Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
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。
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
2008年7月1日
初级完成 (实际的)
2010年10月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2013年1月2日
首先提交符合 QC 标准的
2013年1月7日
首次发布 (估计)
2013年1月9日
研究记录更新
最后更新发布 (估计)
2013年1月9日
上次提交的符合 QC 标准的更新
2013年1月7日
最后验证
2010年10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.