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Recruiting Phase 3 NCT07285291

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

Phase 3 – large-scale trial before approval
Conditions: Hyperphosphatemia Patients on Hemodialysis

Sponsor: Taisho Pharmaceutical Co., Ltd.

trial.available_in: БГ
Overview
A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
Who can participate
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 -3) 2. Patients aged \>=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of \>= 5.5 mg/dL and \< 10.0 mg/dL at Visit 1 (Week -3) 4. 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) Exclusion Criteria: 1. Patients with confirmed serum intact PTH concentration \> 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Interventions
TS-172 20~60 mg/day
DRUG
Placebo
DRUG
Locations 1
Japan (1)
Taisho Pharmaceutical Co., Ltd selected site
Tokyo
Taisho Director Taisho Pharmaceutical Co., Ltd selected site
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.01.2026
Completion date
29.12.2026
Registry ID
NCT07285291
Source
clinicaltrials.gov
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