Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation (EVITRA)
2019年2月27日 更新者:Imperial College London
Study to Compare Once-daily Extended Release Tacrolimus Versus Twice-daily Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce the Risk of Allosensitisation
Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
研究概览
研究类型
介入性
注册 (预期的)
64
阶段
- 第四阶段
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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London、英国、W12 0HS
- 招聘中
- Imperial College Healthcare NHS Trust
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接触:
- Michelle Willicombe
- 电话号码:02083836641
- 邮箱:imperial.evitra.study@nhs.net
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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
18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
Inclusion Criteria:
- Able to give informed consent.
- Male or female, at least 18 years of age.
- Has renal allograft failure and is due to start haemodialysis therapy or within 28 days following starting dialysis.
- Has been already activated on the transplant wait list or is undergoing work up to be reactivated on the transplant list.
- Has no indication for graft nephrectomy at the time of transplant failure.
- Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.
Exclusion Criteria:
- Has another functioning organ transplanted (eg. pancreas, liver, cardiac) at the time of kidney allograft failure.
- Allograft failure within a month of transplant.
- Patients who are due to receive or receiving peritoneal dialysis following graft failure.
- Patients with detectable DSA at the time of allograft failure
- Receiving an extended release preparation of tacrolimus as immunotherapy at the time of graft failure.
- Requires continuation of maintenance immunosuppression other than prednisolone or tacrolimus (eg. Mycophenolate mofetil or sirolimus).
- Patients who on IR-FK conversion would require less than 0.75mg of Envarsus.
- HLA type of donor is unknown.
- Has a history of, or active co-morbidity that in the Investigator's opinion, could affect the conduct of the study.
- Has any condition at the time of recruitment which would prohibit or pose a relative contraindication for the continued use of tacrolimus to a target trough level of between 3-5ng/ml
- Active bacterial, viral (including CMV and EBV) or parasitic infections, including tuberculosis that, in the Investigator's opinion, could affect the conduct of the study.
- Has active malignancy.
- Female patients of child bearing age, who wish to consider pregnancy.
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:预防
- 分配: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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无干预:Immediate release tacrolimus
Patients will continue on immediate release tacrolimus
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有源比较器:Extended release tacrolimus
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Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation
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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 |
---|---|---|
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
大体时间:24 months
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Number of patients who develop new DSA in each group
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24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Medication adherence measurement
大体时间:24 months
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Will be measured by BAASIS questionnaire (comparison of scores)
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24 months
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Health-Related Quality of Life measurement
大体时间:24 months
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Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D - 5L Questionnaire |
24 months
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Coefficient of variation of tacrolimus levels at 24 months post allograft failure.
大体时间:24 months
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Incorporating all study visit trough tacrolimus levels (standard deviation/mean)
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24 months
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Adverse events
大体时间:24 months
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Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy
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24 months
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Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT
大体时间:24 months
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Will be calculated by using the NHSBT calculator
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24 months
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Proportion of patients retransplanted during the study period
大体时间:24 months
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Proportion of patients in each arm receiving a transplant
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24 months
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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。
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 (实际的)
2018年11月1日
初级完成 (预期的)
2021年11月1日
研究完成 (预期的)
2023年11月1日
研究注册日期
首次提交
2018年9月20日
首先提交符合 QC 标准的
2018年9月24日
首次发布 (实际的)
2018年9月28日
研究记录更新
最后更新发布 (实际的)
2019年2月28日
上次提交的符合 QC 标准的更新
2019年2月27日
最后验证
2019年2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.
Envarsus Oral Product的临床试验
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