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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperphosphatemia Patients on Peritoneal Dialysis
• Intervention / Treatment: Drug: 'TS-172 20~60 mg/day

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Taisho selected site
    • Contact: Taisho Director; 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 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 =< 7.0 mg/dL at Visit 1 (Week -4)
5. Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is >= 5.5 mg/dL and < 10.0 mg/dL.

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 16
Concentration of corrected serum calcium	Up to Week 16
Serum Ca × P product	Up to Week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TS172-03-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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