NCT00767637已完成2 期
Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis
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
- 14
- 主要终点
- Changes in pre-dialysis serum phosphate levels
研究概览
简要总结
To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication
排除标准
- •Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Lanthanum Carbonate (BAY77-1931) (Drug)
结局指标
主要结局
Changes in pre-dialysis serum phosphate levels
时间窗: Every 2 weeks
次要结局
- Changes in corrected serum calcium level(Every 2 weeks)
- Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)(Every 2 weeks)
- Changes in the product of serum calcium and phosphate(Every 2 weeks)
- Changes in serum intact-PHT levels(Every 2 weeks)
- Changes in bone metabolism markers(Every 2 weeks)
研究者
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