Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients (BOOST_TX_SubA)
Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established.
This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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-
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Vienna、奥地利、1090
- Medical University of Vienna
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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:
- Patient has received a kidney transplantation
- > 18 years of age
- No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
- Maintenance immunosuppression with mycophenolate or azathioprine
Exclusion Criteria:
- acute illness with fever
- Prior documented infection with SARS-CoV-2
- triple anticoagulation therapy
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
- Subject is pregnant or breast feeding
- SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination > 0.8 BAU/mL
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 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:Immunosuppression reduction
Participants stop mycophenolate or azathioprine for two weeks peri-vaccination.
Treatment is stopped on week before vaccination and only restarted one week after vaccination
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participants stop mycophenolate or azathioprine one week before additional vaccine dose.
Overall medication is stopped for two weeks.
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有源比较器:No immunosuppression reduction
no alterations to immunosuppression
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participants do not alter immunosuppresion
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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 |
---|---|---|
Seroconversion at 4 weeks
大体时间:4 weeks
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Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Seroconversion at 7 days
大体时间:7 days
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Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination
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7 days
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Antibody levels at 4 weeks
大体时间:4 weeks
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SARS-CoV-2 antibody levels at 4 weeks after vaccination
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4 weeks
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Donor specific antibodies
大体时间:4 weeks
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Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing
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4 weeks
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Donor-derived cell free DNA
大体时间:4 weeks
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Donor-derived at 4 weeks after mycophenolate / azathioprine pausing
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4 weeks
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Creatinine levels
大体时间:4 weeks
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Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing
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4 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BOOST_TX_SubA
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.
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