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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2026-12-29

Brief Summary

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

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Detailed Description

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Conditions

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Hyperphosphatemia Patients on Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TS-172 20~60 mg/day

Group Type EXPERIMENTAL

TS-172 20~60 mg/day

Intervention Type DRUG

oral administration of TS-172 20\~60 mg/day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral administration of placebo

Interventions

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TS-172 20~60 mg/day

oral administration of TS-172 20\~60 mg/day

Intervention Type DRUG

Placebo

oral administration of placebo

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No