NCT00646932已完成2 期
A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism 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
- Abbott
- 入组人数
- 25
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.
详细描述
The purpose of this study is pharmacokinetic & tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure
排除标准
- •Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study
研究组 & 干预措施
1
Experimental
干预措施: paricalcitol (Drug)
2
Experimental
干预措施: paricalcitol (Drug)
3
Experimental
干预措施: paricalcitol (Drug)
4
Experimental
干预措施: paricalcitol (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 2 weeks
次要结局
- Safety(2 weeks)
研究者
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