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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperphosphatemia Patients on Hemodialysis
• Intervention / Treatment: Drug: Placebo; Drug: TS-172 20~60 mg/day

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Taisho Pharmaceutical Co., Ltd. Taisho Pharmaceutical Co., Ltd.; Phone Number: 81-3-3985-1118; Email: shu_chiken@taisho.co.jp
• Study Contact Backup: Name: Taisho Director Taisho Director

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Taisho Pharmaceutical Co., Ltd selected site
    • Contact: Taisho Director Taisho Pharmaceutical Co., Ltd selected site; Phone Number: 81-3-3985-1118; Email: shu_chiken@taisho.co.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral administration of placebo
Experimental: TS-172 20~60 mg/day	Drug: TS-172 20~60 mg/day; oral administration of TS-172 20~60 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement rate of the target serum phosphorus level	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in serum concentration of phosphorus	Up to Week 8
Concentration of corrected serum calcium	Up to Week 8
Serum Ca × P product	Up to Week 8

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 29, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TS172-03-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No