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

A clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis

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 peritoneal dialysis (CAPD or APD) 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 binder and whose dosing regimen for all phosphate-lowering agents (phosphate binder and tenapanor hydrochloride) 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 =< 7.0 mg/dL at Visit 1 (Week -4)
5. Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) 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 4 (Week 0)
2. Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (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 16 weeks

Achievement rate of the target serum phosphorus level at Week 8

+81-3-6665-0572

April. 06, 2026

No

none