NCT00463021已完成4 期
A Phase 4, Multi Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.
Genzyme, a Sanofi Company8 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Dose Conversion
研究概览
简要总结
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
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
- None
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
- •The subject must be receiving hemodialysis three times per week for a minimum of six months.
- •The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- •The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
排除标准
- •In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- •Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- •The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
- •Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
结局指标
主要结局
Dose Conversion
时间窗: 10 weeks
次要结局
未报告次要终点
研究者
研究点 (8)
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