A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis with Phosphate Binders

Phase 2

Recruiting

• Conditions: Hyperphosphatemia Patients on Hemodialysis
• Interventions: Drug: TS-172; Drug: Placebo

• Registration Number: NCT06745518
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

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: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-08-19
• Study Completion: 2025-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS-172	TS-172	-
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