A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
NCT ID: NCT05699239
Last Updated: 2025-02-28
Study Results
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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COMPLETED
PHASE2
326 participants
INTERVENTIONAL
2023-02-08
2023-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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10 mg bid
Patients receive TS-172 10 mg bid.
TS-172 10mg bid
oral administration of TS-172 10 mg bid
30 mg bid
Patients receive TS-172 30 mg bid.
TS-172 30mg bid
oral administration of TS-172 30 mg bid
60 mg bid
Patients receive TS-172 60 mg bid.
TS-172 60mg bid
oral administration of TS-172 60 mg bid
20 mg tid
Patients receive TS-172 20 mg tid.
TS-172 20mg tid
oral administration of TS-172 20 mg tid
Placebo
Patients receive placebo.
Placebo
oral administration of placebo
Interventions
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TS-172 10mg bid
oral administration of TS-172 10 mg bid
TS-172 30mg bid
oral administration of TS-172 30 mg bid
TS-172 60mg bid
oral administration of TS-172 60 mg bid
TS-172 20mg tid
oral administration of TS-172 20 mg tid
Placebo
oral administration of placebo
Eligibility Criteria
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Inclusion Criteria
2. Patients aged ≥18 to \<80 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)
Exclusion Criteria
2. Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
18 Years
79 Years
ALL
No
Sponsors
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Taisho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Taisho Director
Role: STUDY_DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Locations
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Taisho Pharmaceutical Co., Ltd selected site
Tokyo, , Japan
Countries
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Other Identifiers
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TS172-02-01
Identifier Type: -
Identifier Source: org_study_id
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