A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

NCT07285304 | Recruiting Phase 3

• 1 other identifier: TS172-03-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.

Conditions

Hyperphosphatemia Patients on Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Up to 26 weeks or up to 52 weeks

Study Arms (1)

TS-172

EXPERIMENTAL

Drug: TS-172

Interventions

TS-172 DRUG

oral administration of TS-172 20\~60 mg/day

TS-172

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients aged ≥18 years at the time of obtaining informed consent
• 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)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

RECRUITING

Central Study Contacts

Taisho Pharmaceutical Co., Ltd.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)