A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia patients on hemodialysis

Taisho Pharmaceutical Co., LTD.0 个研究点目标入组 100 人开始时间: 2025年1月6日最近更新: 2025年3月21日

适应症

试验速览

暂无简介。

•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)
•Patients aged >=18 years at the time of obtaining informed consent
•Patients with a 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.
•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.

•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.)

Achievement rate of the target serum phosphorus level at Week 8

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发起方