jRCT2031240568进行中（未招募）不适用
A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
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.)
结局指标
主要结局
-
Achievement rate of the target serum phosphorus level at Week 8
次要结局
未报告次要终点
研究者
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