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

A clinical study of TS-172 in hyperphosphatemia patients on hemodialysis

Seiji Mita

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Management Development Development Headquarters

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Recruiting

April. 14, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

'1. 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)
2. Patients aged >= 18 years at the time of obtaining informed consent
3. 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).
4. Patients with serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
5. 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.

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 4 (Week -1)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Both

Hyperphosphatemia

Oral administration of TS-172 20~60 mg/day for 8 weeks

Achievement rate of the target serum phosphorus level at Week 8

+81-3-6665-0572

April. 06, 2026

No

none