NCT00769496已完成2 期
A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 145
- 主要终点
- Changes in pre-dialysis serum phosphate levels
研究概览
简要总结
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
排除标准
- •Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY 77-1931 (Drug)
结局指标
主要结局
Changes in pre-dialysis serum phosphate levels
时间窗: Every 4 weeks
次要结局
- Changes in the product of serum calcium and phosphate(Every 4 weeks)
- Changes in serum intact-PHT levels(Every 4 weeks)
- Changes in bone metabolism markers(Every 4 weeks)
- Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)(Every 4 weeks)
- Changes in corrected serum calcium level(Every 4 weeks)
研究者
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