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

NCT06745531 | Completed Phase 3

• 1 other identifier: TS172-03-01
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperphosphatemia Patients on Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Achievement rate of the target serum phosphorus level

  Week 8

Secondary Outcomes (3)

• 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

Study Arms (2)

TS-172 20~60 mg/day

EXPERIMENTAL

Drug: TS-172 20~60 mg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TS-172 20~60 mg/day DRUG

oral administration of TS-172 20\~60 mg/day

TS-172 20~60 mg/day

Placebo DRUG

oral administration of placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients aged \>=18 years at the time of obtaining informed consent
• Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -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.

You may not qualify if:

• Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
• Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
• Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 6, 2025
• Primary Completion: October 13, 2025
• Study Completion: October 20, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

JP (1)