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

A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.

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 -2)
2. Patients aged ≥18 years at the time of obtaining informed consent
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 -2)
4. 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 Criteria:

1. Patients with confirmed serum intact PTH concentration >500 pg/mL at Visit 1 (Week -2)
2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)