Actively Recruiting
An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Led by Taisho Pharmaceutical Co., Ltd. · Updated on 2026-05-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TS-172 in adults with hyperphosphatemia who are receiving hemodialysis due to chronic kidney disease. This open-label, single-arm clinical study aims to assess how well TS-172 controls serum phosphorus levels in this patient group. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and focuses on patients who have been on hemodialysis three times a week for at least 12 weeks. Participants will receive oral TS-172 once daily at doses ranging from 20 to 60 mg. The study monitors the achievement rate of target serum phosphorus levels by Week 8. Secondary measures include changes in serum phosphorus concentration, corrected serum calcium levels, and the serum calcium-phosphorus product up to Week 8. During the study, participants will undergo regular blood tests to measure phosphorus and calcium levels and monitor parathyroid hormone concentrations. Researchers will track changes from baseline to evaluate treatment effects. The study does not involve blinding or placebo groups. Participants will be followed from screening through Week 8 to assess safety and efficacy outcomes.
CONDITIONS
Brief Title
A Clinical 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 prior to screening
- Patients aged 18 years or older at the time of informed consent
- Receiving at least one phosphate-lowering agent at an approved dose with no dose changes in the last 4 weeks before screening
- Serum phosphorus concentration between 3.5 mg/dL and less than 5.5 mg/dL at screening
- Serum phosphorus increased by at least 1.0 mg/dL and is between 5.5 mg/dL and less than 10.0 mg/dL at specified pre-treatment visits
You will not qualify if you...
- Serum intact parathyroid hormone concentration above 500 pg/mL from screening to treatment start
- Serum phosphorus concentration equal to or above 10.0 mg/dL during screening visits
- Previous parathyroid interventions such as parathyroidectomy or percutaneous 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 8 weeks
Participants receive oral administration of TS-172 20 to 60 mg per day while continuing hemodialysis.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Taisho 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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