NCT00091481已完成4 期
A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 201
- 试验地点
- 31
- 主要终点
- Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
研究概览
简要总结
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage V Chronic Kidney Disease
- •Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
排除标准
- 未提供
结局指标
主要结局
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
次要结局
- The incidence rate for hypercalcemia
- Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
- The incidence rate for hyperphosphatemia
研究者
研究点 (31)
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