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CompletedNCT06745531Updated Nov 17, 2025

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

A Phase 3 interventional study of TS-172 20~60 mg/day and Placebo in Hyperphosphatemia Patients on Hemodialysis, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hyperphosphatemia Patients on Hemodialysis
03

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 years at the time of obtaining informed consent
  3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4)
  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.

Exclusion criteria

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 4 (Week -1)
  3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    TS-172 20~60 mg/day

    Drug: TS-172 20~60 mg/day

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTS-172 20~60 mg/day

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

  • DrugPlacebo

    oral administration of placebo

06

What researchers measure

Primary outcomes

  1. Achievement rate of the target serum phosphorus level

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in serum concentration of phosphorus

    Time frame: Up to Week 8

  2. Concentration of corrected serum calcium

    Time frame: Up to Week 8

  3. Serum Ca × P product

    Time frame: Up to Week 8

07

Study locations

1 site
  • Taisho Pharmaceutical Co., Ltd selected site
    Tokyo, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06745531
Lead sponsor
Taisho Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
Jan 6, 2025
Primary completion
Oct 13, 2025
Completion
Oct 20, 2025
Last update
Nov 17, 2025

Study contacts

Taisho Director
study director · Taisho Pharmaceutical Co., Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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