NCT00441545已完成3 期
A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 182
- 试验地点
- 43
- 主要终点
- Change From Baseline in Serum Phosphorus Levels at 4 Weeks
研究概览
简要总结
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
详细描述
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults with end stage renal disease who are receiving dialysis
排除标准
- •Subjects with significant gastrointestinal disorders
- •Subjects who are pregnant or nursing
- •Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
- •Subjects who are HIV positive
- •Subjects with clinical significant liver disease
研究组 & 干预措施
1
Experimental
Fosrenol (Lanthanum carbonate)
干预措施: Fosrenol (Lanthanum Carbonate) (Drug)
2
Active Comparator
Sevelamer hydrochloride
干预措施: Sevelamer hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
时间窗: 4 weeks
次要结局
- Change From Baseline in Serum Calcium Levels at 4 Weeks(4 weeks)
- Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks(Baseline and 4 weeks)
- Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks(4 weeks)
研究者
研究点 (43)
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