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

NCT ID: NCT07285304

Last Updated: 2025-12-16

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-07-31

Brief Summary

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

Detailed Description

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Conditions

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Hyperphosphatemia Patients on Hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TS-172

Group Type EXPERIMENTAL

TS-172

Intervention Type DRUG

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

Interventions

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TS-172

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

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 -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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Taisho Pharmaceutical Co., Ltd.

Role: CONTACT

81-3-3985-1118

Facility Contacts

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Taisho Director Taisho Pharmaceutical Co., Ltd selected site

Role: primary

81-3-3985-1118

Other Identifiers

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TS172-03-03

Identifier Type: -

Identifier Source: org_study_id