NCT03822507已完成3 期
A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 34
- 主要终点
- Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
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 (Participant, Investigator)
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
- •Personally submitted written voluntary informed consent to participate in the study
- •Aged ≧18 years at the time of consent
- •Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
- •Intact PTH level (centrally measured) of >300 pg/mL at screening
- •Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening
排除标准
- •Treatment with cinacalcet hydrochloride within 2 weeks before screening
- •Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
- •Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
- •Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
- •Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
- •Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
- •Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
- •Uncontrolled hypertension and/or diabetes
研究组 & 干预措施
KHK7580 1mg-12mg
Experimental
干预措施: KHK7580 (Drug)
Cinacalcet 25mg-100mg
Active Comparator
干预措施: Cinacalcet Hydrochloride (Drug)
结局指标
主要结局
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
时间窗: Week 50- Week 52
次要结局
- Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period(Week 50- Week 52)
- Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period(Week 50- Week 52)
- Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period(Week 50- Week 52)
- Intact PTH level(Week 50- Week 52)
- corrected serum Ca level(Week 50- Week 52)
- serum P level(Week 50- Week 52)
- Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period(Week 50- Week 52)
研究者
研究点 (34)
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