A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Taisho Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Hyperphosphatemia Patients on Hemodialysis

Treatments: Drug: TS-172

Study type: Interventional

Funder types: Industry

Identifiers

NCT07285304

TS172-03-03

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

TS-172

Experimental group

Treatment:

Drug: TS-172