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临床试验/NCT07285304
NCT07285304招募中3 期

A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Taisho Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年12月1日最近更新:
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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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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A Long-term Study of TS-172 in Hyperphosphatemia... | 临床试验