NCT05699239已完成2 期
A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
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
- 326
- 试验地点
- 1
- 主要终点
- Change from baseline in serum concentration of phosphorus
研究概览
简要总结
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
- •Patients aged ≥18 to <80 years at the time of obtaining informed consent
- •Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)
排除标准
- •Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
- •Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
- •Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
研究组 & 干预措施
60 mg bid
Experimental
Patients receive TS-172 60 mg bid.
干预措施: TS-172 60mg bid (Drug)
10 mg bid
Experimental
Patients receive TS-172 10 mg bid.
干预措施: TS-172 10mg bid (Drug)
30 mg bid
Experimental
Patients receive TS-172 30 mg bid.
干预措施: TS-172 30mg bid (Drug)
20 mg tid
Experimental
Patients receive TS-172 20 mg tid.
干预措施: TS-172 20mg tid (Drug)
Placebo
Placebo Comparator
Patients receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in serum concentration of phosphorus
时间窗: Week 4
次要结局
- Concentration of corrected serum calcium(Up to Week 4)
- Achievement ratio of patients with the target serum concentration of phosphorus(Up to Week 4)
- Serum calcium times phosphorus product(Up to Week 4)
研究者
研究点 (1)
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