NCT00123461已完成4 期
A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).
Genzyme, a Sanofi Company33 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2005年7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
- 70
- 试验地点
- 33
- 主要终点
- Laboratory measurement of intact parathyroid hormone (iPTH)
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4
- •Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
- •CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min
排除标准
- •Serum cCa > 9.5 mg/dL
- •Serum P > 4.6 mg/dL
- •Abnormal liver functions
- •Anticipated requirement for maintenance hemodialysis
- •Use of active vitamin D sterol therapy
结局指标
主要结局
Laboratory measurement of intact parathyroid hormone (iPTH)
时间窗: 6 months
次要结局
- Laboratory measurement of serum bone markers(6 months)
研究者
研究点 (33)
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