NCT00151931已完成3 期
A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis
适应症
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
- 456
- 主要终点
- Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
研究概览
简要总结
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Males and females of childbearing potential agree to take adequate precautions to prevent contraception
- •Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
- •Patient requires treatment for hyperphosphataemia
排除标准
- •Pregnant or lactating women
- •Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
- •Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
- •Patients who are HIV+
- •Patients with any significant gastrointestinal surgery or disorders
结局指标
主要结局
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
时间窗: Week 3 and Week 5
次要结局
- Treatment emergent adverse events(Throughout the study period of approximately 20 months.)
研究者
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