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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260053

Enrollment

Registered

2026-04-16

Start date

2026-05-13

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia

Interventions

Oral administration of TS-172 20~60 mg/day for 16 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: '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 == 5.5 mg/dL and < 10.0 mg/dL.

Exclusion criteria

Exclusion criteria: '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.)

Design outcomes

Primary

Measure	Time frame
Achievement rate of the target serum phosphorus level at Week 8	—

Contacts

Public ContactDevelopment Headquarters Management

Taisho Pharmaceutical Co., LTD.

shu_chiken@taisho.co.jp+81-3-3985-1118

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026