An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on hemodialysis

未提供0 个研究点目标入组 30 人开始时间: 待定

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 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.

•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.)

发起方

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