RecruitingPhase 3NCT07285304
A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Sponsor
Taisho Pharmaceutical Co., Ltd.
Enrollment
300 participants
Start Date
Dec 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria2
- 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.)
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Interventions
DRUGTS-172
oral administration of TS-172 20\~60 mg/day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07285304