NCT07548853招募中3 期
An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 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
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis
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 peritoneal dialysis (CAPD or APD) at least 12 weeks prior to Visit 1 (Week -4)
- •Patients aged >= 18 years at the time of obtaining informed consent
- •Patients who are receiving at least one phosphate binder and whose dosing regimen for all phosphate-lowering agents (phosphate binder and tenapanor hydrochloride) has been unchanged during the last 4 weeks prior to Visit 1 (Week -4).
- •Patients with serum phosphorus concentration of >= 3.5 mg/dL and =< 7.0 mg/dL at Visit 1 (Week -4)
- •Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) 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 4 (Week 0)
- •Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (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)
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 16)
- Concentration of corrected serum calcium(Up to Week 16)
- Serum Ca × P product(Up to Week 16)
研究者
研究点 (1)
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