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

Taisho Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Hyperphosphatemia Patients on Hemodialysis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06745531

TS172-03-01

Details and patient eligibility

About

A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia

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 -4)
2. Patients aged >=18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is >= 5.5 mg/dL and < 10.0 mg/dL.

Exclusion criteria

1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
3. 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