Actively Recruiting
A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Led by Taisho Pharmaceutical Co., Ltd. · Updated on 2025-12-16
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of the drug TS-172 in patients with hyperphosphatemia who are undergoing hemodialysis. This Phase 3 study focuses on patients who have chronic kidney disease and have been receiving hemodialysis or hemodiafiltration three times a week for at least 12 weeks. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and aims to assess the impact of TS-172 on controlling phosphate levels. Participants will receive oral TS-172 at doses ranging from 20 to 60 mg per day while continuing their prescribed phosphate binder regimen without changes in dosage during the study. The trial includes a treatment period lasting up to 52 weeks to monitor the drug's safety and efficacy in managing serum phosphorus levels within a specified range. No placebo or comparator groups are mentioned, and the study is open-label without masking. During the trial, participants will have regular assessments to monitor adverse events and serum phosphorus concentrations. The primary outcome measure is the incidence of adverse events within 26 to 52 weeks of treatment. Patients must meet specific eligibility criteria regarding their dialysis treatment, phosphate binder use, and serum phosphorus levels. The total participation duration will be at least one year from the start of treatment, with safety monitored throughout the study period.
CONDITIONS
Brief Title
A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hyperphosphatemia patients with chronic kidney disease receiving hemodialysis or hemodiafiltration three times a week for at least 12 weeks before the study start
- Patients aged 18 years or older at the time of consent
- Patients prescribed at least one phosphate binder at an approved dose with no dosage changes in the last 2 weeks before study start
- Serum phosphorus concentration between 3.5 mg/dL and 7.0 mg/dL at the first or second study visit
You will not qualify if you...
- Patients with serum intact parathyroid hormone concentration greater than 500 pg/mL at the first study visit
- Patients who have had previous parathyroid interventions such as surgery or ethanol injection therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive oral administration of TS-172 daily to manage hyperphosphatemia while undergoing hemodialysis.
Weekly visits for up to 52 weeks
Trial Site Locations
Total: 1 location
1
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Actively Recruiting
Research Team
T
Taisho Pharmaceutical Co., Ltd.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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