A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Phase 3

Recruiting

• Conditions: Hyperphosphatemia Patients on Hemodialysis
• Interventions: Drug: TS-172 20~60 mg/day; Drug: Placebo

• Registration Number: NCT06745531
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-01
• Study Start: 2025-01-06
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-23
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 -4)
2. Patients aged >=18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) 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 5 (Week 0)
2. Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS-172 20~60 mg/day	TS-172 20~60 mg/day	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Achievement rate of the target serum phosphorus level	Week 8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan