NCT00150566已完成3 期
A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis
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
- 460
- 主要终点
- Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
研究概览
简要总结
The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Subjects with ESRD who currently require treatment for hyperphosphatemia
- •Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study
排除标准
- •Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
- •Hypocalcaemia
- •Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL
- •Any significant gastrointestinal surgery or gastrointestinal disorders
结局指标
主要结局
Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
时间窗: 4 & 8 weeks
次要结局
- Tolerability(8 weeks)
- Quality of Life(8 weeks)
- Subject/physician satisfaction and preference questionnaires(8 weeks)
研究者
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