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NCT Number: NCT07548840

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

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

Recruiting

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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

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 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.

Exclusion criteria

  • 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.)

Treatment and study plan

TS-172 20~60 mg/day

Drug

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

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

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

An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
May 15, 2026

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.

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