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

A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250548

Enrollment

100

Registered

2025-12-04

Start date

2026-01-09

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 8 weeks with phosphate binders

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 -3) 2. Patients aged >=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -3) 4. 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 -3)

Exclusion criteria

Exclusion criteria: 1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0) 2. 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 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