一项旨在了解更多关于 Molidustat 治疗日本男性和女性肾性贫血的长期安全性和有效性的研究
Molidustat治疗肾性贫血患者的长期特殊用药调查
In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.
In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.
The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Many Locations、日本
- Many locations
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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
取样方法
研究人群
Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
描述
Inclusion Criteria:
- Female or male participants with a diagnosis of renal anemia
- Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
- Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
- Signed informed consent
Exclusion Criteria:
- Contra-indications according to the local marketing authorization
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Molidustat
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators |
Tablets, administered orally at the discretion of investigators |
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 safety events
大体时间：Up to approximately 24 months
|
Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease (ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients |
Up to approximately 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
血红蛋白 (Hb) 水平相对于基线的绝对变化
大体时间：最长约 24 个月
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最长约 24 个月
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血红蛋白 (Hb) 水平相对于基线的百分比变化
大体时间：最长约 24 个月
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最长约 24 个月
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Hb 水平从基线开始的时间过程
大体时间：最长约 24 个月
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最长约 24 个月
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Hb 水平在目标范围内的参与者比例
大体时间：最长约 24 个月
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最长约 24 个月
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Incidence of safety events in dialysis and non-dialysis participants
大体时间：Up to approximately 24 months
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Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease(ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients |
Up to approximately 24 months
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Incidence of safety events (important identified risk and important potential risk) by patient background
大体时间：Up to approximately 24 months
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Important identified risk: "Thromboembolism" and "Hypertension" Important potential risk: "Malignant tumor", "Retinal hemorrhage", "Major Adverse Cardiovascular Events (MACE) without thromboembolism", "Interstitial lung disease(ILD)" and "Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD)" |
Up to approximately 24 months
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Absolute changes of Hb levels from baseline in sub-group analysis
大体时间：Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
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Percentage changes of Hb levels from baseline in sub-group analysis
大体时间：Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
其他相关的 MeSH 术语
其他研究编号
- 21319
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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
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