NCT06745531已完成3 期
A Phase 3, Randomized, Placebo-controlled, Double-blind 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
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Achievement rate of the target serum phosphorus level
研究概览
简要总结
A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia
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 —（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 years at the time of obtaining informed consent
- •Patients with a serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
- •Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is >= 5.5 mg/dL and < 10.0 mg/dL.
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 4 (Week -1)
- •Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
研究组 & 干预措施
TS-172 20~60 mg/day
Experimental
干预措施: TS-172 20~60 mg/day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Achievement rate of the target serum phosphorus level
时间窗: Week 8
次要结局
- Change from baseline in serum concentration of phosphorus(Up to Week 8)
- Concentration of corrected serum calcium(Up to Week 8)
- Serum Ca × P product(Up to Week 8)
研究者
研究点 (1)
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