NCT00664066终止不适用
A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo
研究概览
简要总结
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect & describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent.
- •Patients must already be receiving DYNEPO treatment at time of study entry.
- •Patients who are likely to receive DYNEPO for at least 1 year.
排除标准
- •Known intolerance to EPO of any of its excipients
- •Known of suspected Pure Red Cell Aplasia (PRCA)
结局指标
主要结局
Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo
时间窗: up to 3 years
This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
次要结局
未报告次要终点
研究者
研究点 (2)
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