NCT03226171已完成2 期
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
研究概览
简要总结
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average serum PTH>240 pg/mL during 2 weeks at the screening
- •Serum corrected Ca≧8.4 mg/dL at the screening
- •Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
排除标准
- •Primary hyperparathyroidism
- •Severe liver disease
- •Severe Cardiac disease
- •History or family history of Long QT syndrome
- •Malignant tumor
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •A history of severe drug allergy
研究组 & 干预措施
Dose-adjusted SK-1403
Experimental
干预措施: Dose-adjusted SK-1403 (Drug)
结局指标
主要结局
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
时间窗: 18 weeks
Assessed by laboratory test value
次要结局
- Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively(18 weeks)
- Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product(52 weeks)
研究者
研究点 (1)
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