JPRN-jRCT2031220587进行中(未招募)2 期
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Mita Seiji0 个研究点目标入组 150 人开始时间: 2023年1月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 80age old(—)
- 性别
- All
入选标准
- •1. 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 -4)
- •2. Patients aged >=18 to <80 years at the time of obtaining informed consent
- •3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and =< 6.0 mg/dL at Visit 1 (Week -4)
排除标准
- •1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
- •2. Patients with serum phosphorus concentration >=10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
- •3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
研究者
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