NCT07285291招募中3 期
A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 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, phosphate binder-combination 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 —（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 -3)
- •Patients aged >=18 years at the time of obtaining informed consent
- •Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -3)
- •Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3)
排除标准
- •Patients with confirmed serum intact PTH concentration > 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
- •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
- Serum Ca × P product(Up to Week 8)
- Change from baseline in serum concentration of phosphorus(Up to Week 8)
- Concentration of corrected serum calcium(Up to Week 8)
研究者
研究点 (1)
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