A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

NCT07548840 | Not Yet Recruiting Phase 3

• 1 other identifier: TS172-03-11
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on hemodialysis

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 (1)

'TS-172 20~60 mg/day

EXPERIMENTAL

Drug: TS-172 20~60 mg/day

Interventions

TS-172 20~60 mg/day DRUG

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

'TS-172 20~60 mg/day

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 at least 12 weeks prior to Visit 1 (Week -4)
• Patients aged \>= 18 years at the time of obtaining informed consent
• Patients who are receiving at least one phosphate-lowering agent (phosphate binder and tenapanor hydrochloride) within approved dosage, and whose dosing regimen for all phosphate-lowering agents has been unchanged during the last 4 weeks prior to Visit 1 (Week -4).
• Patients with 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 Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Taisho Pharmaceutical Co., Ltd.

CONTACT

81-3-3985-1118; shu_chiken@taisho.co.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share