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

Taisho Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Hyperphosphatemia Patients on Hemodialysis

Treatments: Drug: TS-172 20~60 mg/day; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07285291

TS172-03-02

Details and patient eligibility

About

A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

Enrollment: 100 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 -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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

TS-172 20~60 mg/day

Experimental group

Treatment:

Drug: TS-172 20~60 mg/day

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo