NCT00567723已完成不适用
A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 2,105
- 试验地点
- 189
- 主要终点
- Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)
研究概览
简要总结
Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patient must have ESRD and be receiving dialysis
- •Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
- •Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
- •Patient must be 18 years of age or older
排除标准
- •Patients that do not meet inclusion criteria
结局指标
主要结局
Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)
时间窗: 5 years
次要结局
- Compare the incidence of selected morbidities among three groups of patients with ESRD(5 years)
研究者
研究点 (189)
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