NCT07548840招募中3 期
An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
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
研究概览
简要总结
An open-label, single-arm clinical study 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 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-lowering agent (phosphate binder and tenapanor hydrochloride) within approved dosage, and whose dosing regimen for all phosphate-lowering agents 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 < 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)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal DialysisHyperphosphatemia Patients on Peritoneal DialysisNCT07548853Taisho Pharmaceutical Co., Ltd.30
招募中
3 期
A Long-term Study of TS-172 in Hyperphosphatemia Patients on HemodialysisNCT07285304Taisho Pharmaceutical Co., Ltd.300
招募中
4 期
Study to compare the ability of the drugs ferric citrate and sevelamer carbonate to lower serum phosphate levels in patiets with chronic kidney disease.CTRI/2025/11/098235Dr Rajendra Prasad Medical College, Tanda200
进行中（未招募）
不适用
A phase 2 study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate bindersHyperphosphatemiajRCT2031240568Taisho Pharmaceutical Co., LTD.50
招募中
不适用
A phase 3 study of TS-172 in hyperphosphatemia patients on hemodialysisHyperphosphatemiajRCT2031240567Taisho Pharmaceutical Co., LTD.100