NCT00557323已完成不适用
A Long-term, Observational Study to Monitor Mortality, Bone-related Adverse Events and the Safety of Subjects Who Were Recruited Into Study SPD405-309
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 34
- 试验地点
- 16
- 主要终点
- Number of Study-emergent Bone-related Adverse Events (AEs)
研究概览
简要总结
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.
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
- •Any patient who had exposure to lanthanum carbonate in SPD405-309
排除标准
- 未提供
研究组 & 干预措施
1
Patients being treated for hyperphosphatemia with any marketed product
干预措施: Lanthanum carbonate (Drug)
结局指标
主要结局
Number of Study-emergent Bone-related Adverse Events (AEs)
时间窗: 5 years
次要结局
- Number of Study-emergent Deaths(5 years)
研究者
研究点 (16)
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