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

A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

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

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia Patients on Hemodialysis
• Intervention / Treatment: Drug: TS-172 10mg bid; Drug: TS-172 30mg bid; Drug: TS-172 60mg bid; Drug: TS-172 20mg tid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (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 -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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg bid; Patients receive TS-172 10 mg bid.	Drug: TS-172 10mg bid; oral administration of TS-172 10 mg bid
Experimental: 30 mg bid; Patients receive TS-172 30 mg bid.	Drug: TS-172 30mg bid; oral administration of TS-172 30 mg bid
Experimental: 60 mg bid; Patients receive TS-172 60 mg bid.	Drug: TS-172 60mg bid; oral administration of TS-172 60 mg bid
Experimental: 20 mg tid; Patients receive TS-172 20 mg tid.	Drug: TS-172 20mg tid; oral administration of TS-172 20 mg tid
Placebo Comparator: Placebo; Patients receive placebo.	Drug: Placebo; oral administration of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in serum concentration of phosphorus	Week 4

Secondary Outcome Measures

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

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 (Actual): February 8, 2023
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: TS172-02-01

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
• product manufactured in and exported from the U.S.: No