A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Phase 2

Completed

• Conditions: Hyperphosphatemia Patients on Hemodialysis
• Interventions: Drug: TS-172 10mg bid; Drug: TS-172 30mg bid; Drug: TS-172 60mg bid; Drug: TS-172 20mg tid; Drug: Placebo

• Registration Number: NCT05699239
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-26
• Study Start: 2023-02-08
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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 to <80 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

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 5 (Week 0)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg bid	TS-172 10mg bid	Patients receive TS-172 10 mg bid.
30 mg bid	TS-172 30mg bid	Patients receive TS-172 30 mg bid.
60 mg bid	TS-172 60mg bid	Patients receive TS-172 60 mg bid.
20 mg tid	TS-172 20mg tid	Patients receive TS-172 20 mg tid.
Placebo	Placebo	Patients receive placebo.

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum concentration of phosphorus	Week 4

Secondary Outcome Measures

Name	Time	Method
Concentration of corrected serum calcium	Up to Week 4
Achievement ratio of patients with the target serum concentration of phosphorus	Up to Week 4
Serum calcium times phosphorus product	Up to Week 4

Trial Locations

Locations (1)

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