Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07285304

A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hyperphosphatemia Patients on Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location status: Recruiting

Location contact

Taisho Director Taisho Pharmaceutical Co., Ltd selected site

CONTACT

[email protected]

81-3-3985-1118

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -2)
  • Patients aged ≥18 years at the time of obtaining informed consent
  • Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -2)
  • Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)

Exclusion criteria

  • Patients with confirmed serum intact PTH concentration >500 pg/mL at Visit 1 (Week -2)
  • Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Treatment and study plan

TS-172

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 26 weeks or up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Taisho Pharmaceutical Co., Ltd.

CONTACT

[email protected]

81-3-3985-1118

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.