NCT03801980已完成3 期
Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients 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
- 153
- 试验地点
- 1
- 主要终点
- Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
研究概览
简要总结
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum PTH>240 pg/mL 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
- •History of severe drug allergy
研究组 & 干预措施
SK-1403
Experimental
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
干预措施: SK-1403 (Drug)
Placebo
Placebo Comparator
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
时间窗: 24 weeks
Assessed by laboratory test value
次要结局
- Measured values and Changes from baseline in ionized Ca(24 weeks)
- Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.(24 weeks)
- Measured values and Changes from baseline in serum PTH(24 weeks)
- Measured values and Changes from baseline in Ca(24 weeks)
- Measured values and Changes from baseline in P(24 weeks)
- Measured values and Changes from baseline in serum Ca x P product(24 weeks)
研究者
研究点 (1)
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