JPRN-UMIN000039943已完成3 期
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease - A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; 2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl; 3. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after last study drug dose; 4. Women who are pregnant or breastfeeding; 5. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; 6. Known hypersensitivity to any component of the study drug.
研究者
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