A long-term study of TS-172 in hyperphosphatemia patients on hemodialysis

A phase 3 long-term study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250523

Enrollment

300

Registered

2025-11-25

Start date

2025-12-01

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 26 weeks or 52 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 -2) 2. Patients aged >=18 years at the time of obtaining informed consent 3. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -2) 4. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and <= 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)

Exclusion criteria

Exclusion criteria: '1. Patients with confirmed serum intact PTH concentration >500 pg/mL at Visit 1 (Week -2) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Design outcomes

Primary

Measure	Time frame
Adverse event	—

Contacts

Public ContactDevelopment Headquarters Development 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