NCT00792857已完成1 期
Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Safety of a single dose of CTAP201 Injection
研究概览
简要总结
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 18 and 40
- •On maintenance hemodialysis three times per week
- •Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
- •Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- •Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- •Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
- •Visit 2: Serum iPTH value greater than 300 pg/mL
- •Visit 2: Serum Ca x P product less than 56 [mg/dl]2
- •Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
排除标准
- •Taking cytochrome P450 3A inhibitors and/or inducers
- •Abnormal liver functions
研究组 & 干预措施
Doxercalciferol at dose a
Active Comparator
Active at dose a
干预措施: Doxercalciferol (Drug)
CTAP201 Injection at dose a
Experimental
CTAP201 at dose a
干预措施: CTAP201 Injection (Drug)
CTAP201 Injection
Experimental
CTAP201 at dose b or dose c
干预措施: CTAP201 Injection (Drug)
Doxercalciferol
Active Comparator
Active at dose b or dose c
干预措施: Doxercalciferol (Drug)
结局指标
主要结局
Safety of a single dose of CTAP201 Injection
时间窗: Throughout the study
Blood levels of CTAP201 and doxercalciferol
时间窗: Day 1 and Day 15 of each dose level
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
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