Clinical Study on the Effect of PTH on CYP3A4 Activity
赞助:
The Third Xiangya Hospital of Central South University
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 17, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 2, 2018 | ||
| 预计主要完成日期 | September 10, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
the concentration of nifedipine[ Time Frame: at 5-7days ] the concentration of nifedipine |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Clinical Study on the Effect of PTH on CYP3A4 Activity | ||
| 正式标题 ICMJE | Clinical Study on the Effect of PTH on CYP3A4 Activity | ||
| 简要概况 | Parathyroid hormone (PTH) may play an important role in the down-regulation of CYP3A4 expression induced by Chronic kidney diseases (CKD). In the study of molecular mechanism, the research group found that the expression of CYP3A2 metabolic enzyme in rat liver decreased in the state of CKD.And PTH may down-regulate the expression of CYP3A4 metabolic enzyme by inhibiting the expression of Nuclear factor- Kilobuse (NF-kB) p65 subunit |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
200 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 10, 2020 | ||
| 预计主要完成日期 | September 10, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Chinese male or female subjects with an age of 18 or older were included; - The clinical physician diagnosed CKD with hypertension; - The physician decided that nifedipine controlled release tablets should be given. - Subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee; - Subjects will be able to communicate well with the investigator and will be able to complete the study as required. Exclusion Criteria: - Patients with CKD requiring dialysis treatment; - Other clinical reasons that may be considered inappropriate for inclusion by clinicians. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | The Third Xiangya Hospital of Central South University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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