NCT02549404已完成3 期
Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 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
- 137
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
- •Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
- •Intact PTH level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)
排除标准
- •Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
- •Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
- •Severe heart disease;
- •Severe hepatic dysfunction;
- •Uncontrolled hypertension and/or diabetes;
- •Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
- •Primary hyperparathyroidism;
- •Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
研究组 & 干预措施
KHK7580
Experimental
干预措施: KHK7580 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 52 weeks
Adverse Event collection and assessment
次要结局
- Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL(Up to 52 weeks)
- Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline(Up to 52 weeks)
- Mean percent change in intact PTH level from baseline(Up to 52 weeks)
研究者
研究点 (1)
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