RecruitingPhase 3NCT07285291

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

A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Sponsor

Taisho Pharmaceutical Co., Ltd.

Enrollment

100 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

Min Age: 18 Years

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 -3)
Patients aged >=18 years at the time of obtaining informed consent
Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -3)
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 -3)

Patients with confirmed serum intact PTH concentration > 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

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DRUGTS-172 20~60 mg/day

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

DRUGPlacebo

oral administration of placebo

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07285291