A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year (COBALT)
2019年3月25日 更新者：Astellas Pharma S.A.S.
A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.
研究概览
研究类型
观察性的
注册 (实际的)
398
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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Besancon、法国
- Site
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Bordeaux、法国
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Caen、法国
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Chambray les Tours、法国
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Clichy、法国
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Creteil、法国
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Grenoble、法国
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Lille、法国
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Limoges、法国
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Lyon 3、法国
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Lyon 4、法国
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Marseille、法国
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Montpellier、法国
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Nice、法国
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Paris、法国
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Rennes、法国
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Toulouse、法国
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Villejuif、法国
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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
取样方法
非概率样本
研究人群
Liver transplant patients
描述
Inclusion Criteria:
- Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.
Exclusion Criteria:
- Patient participating in an interventional clinical trial at the time of enrolment into the study.
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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1:early conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
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口服
其他名称：
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2:late conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
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口服
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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Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)
大体时间：At baseline
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Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg
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At baseline
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Time of the first tacrolimus trough level (C0) after conversion
大体时间：From baseline to first determination of C0 (up to 6 months)
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Number of days between the conversion date and the date of the first determination of C0 after conversion
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From baseline to first determination of C0 (up to 6 months)
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Number of additional visits considered by the physicians to be due to the conversion (if required)
大体时间：At 6 months and at 1 year follow-up visit
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Percentage of patients with additional visit(s) and percentage of patients without an additional visit
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At 6 months and at 1 year follow-up visit
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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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Reasons for conversion
大体时间：At baseline
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Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice
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At baseline
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Patient profile
大体时间：At baseline
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Sociodemographic data, history of transplantation, comorbidities, complications after transplantation, risk factors, concomitant treatments (other than immunosuppressive protocols) and modification, if required, at 6 months and 1 year after conversion
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At baseline
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Collection of immunosuppressive protocol details
大体时间：At baseline, 6 months and 1 year follow-up visit
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At baseline, 6 months and 1 year follow-up visit
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Time to reach steady state
大体时间：From baseline to first determination of C0 (up to 6 months)
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From baseline to first determination of C0 (up to 6 months)
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Dose ratio at steady state
大体时间：From baseline and up to 6 months post-conversion
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Ratio of daily dose of tacrolimus during achievement of steady state: mg Prograf® at conversion/mg Advagraf® during achievement of steady state.
Percentage of patients with a ratio of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg
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From baseline and up to 6 months post-conversion
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The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®
大体时间：At baseline (Prograf) and during the 45 days after conversion (Advagraf)
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At baseline (Prograf) and during the 45 days after conversion (Advagraf)
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Latest available laboratory data with Prograf® before conversion and with Advagraf®
大体时间：At baseline, 6 months and 1 year follow-up visit
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Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load
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At baseline, 6 months and 1 year follow-up visit
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Compliance with treatment at conversion
大体时间：At baseline and at 1 year after conversion
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Compliance with treatment at conversion (with Prograf® and only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the Morisky questionnaire and a score will be calculated
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At baseline and at 1 year after conversion
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Patients' quality of life at conversion
大体时间：At baseline and at 1 year after conversion
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Patients' quality of life at conversion (with Prograf® only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the European Quality of Life-5 Dimensions 5 level (EQ5D-5L) questionnaire
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At baseline and at 1 year after conversion
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Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate
大体时间：6 months and 1 year
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Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions
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6 months and 1 year
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Occurrence of adverse events and/or effects
大体时间：From baseline until 1 year follow-up visit
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From baseline until 1 year follow-up visit
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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：Medical and Scientific Affairs Manager, Transplantation、Astellas Pharma S.A.S.
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)
2014年6月18日
初级完成 (实际的)
2017年5月3日
研究完成 (实际的)
2017年5月3日
研究注册日期
首次提交
2014年5月9日
首先提交符合 QC 标准的
2014年5月19日
首次发布 (估计)
2014年5月21日
研究记录更新
最后更新发布 (实际的)
2019年3月26日
上次提交的符合 QC 标准的更新
2019年3月25日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
其他研究编号
- FR-ADV-NI-002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.
他克莫司的临床试验
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Ain Shams UniversityNational Hepatology & Tropical Medicine Research Institute完全的