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