NCT07285304招募中3 期
A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.
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
- 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 -2)
- •Patients aged ≥18 years at the time of obtaining informed consent
- •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 -2)
- •Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)
排除标准
- •Patients with confirmed serum intact PTH concentration >500 pg/mL at Visit 1 (Week -2)
- •Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
研究组 & 干预措施
TS-172
Experimental
干预措施: TS-172 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 26 weeks or up to 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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