Actively Recruiting
A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Led by Taisho Pharmaceutical Co., Ltd. · Updated on 2026-04-17
100
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 3 trial to study TS-172, an oral drug, in patients with hyperphosphatemia who are on hemodialysis. The study is designed as randomized, placebo-controlled, and double-blind to evaluate the effect of TS-172 combined with phosphate binders. The purpose is to understand how well TS-172 controls serum phosphorus levels in this patient group. Participants will receive either TS-172 at doses of 20 to 60 mg per day or a placebo, both given by mouth. The study involves continuing the use of phosphate binders at stable doses during the trial. The treatment period lasts up to 8 weeks, during which the impact on phosphorus and calcium levels will be assessed. During the trial, participants will have their serum phosphorus, corrected calcium, and calcium-phosphorus product measured regularly, with the main focus on achieving target phosphorus levels by week 8. The study includes careful monitoring of parathyroid hormone levels and follow-up visits to ensure safety and track treatment effects. Overall participation spans the treatment period and related assessments up to 8 weeks.
CONDITIONS
Brief Title
A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hyperphosphatemia patients with chronic kidney disease receiving hemodialysis 3 times a week for at least 12 weeks before screening
- Age 18 years or older at the time of informed consent
- Serum phosphorus concentration between 5.5 mg/dL and less than 10.0 mg/dL at screening
- Prescribed at least one phosphate binder at an approved dose, with no changes in drug or dosage for 2 weeks before screening
You will not qualify if you...
- Serum intact parathyroid hormone (PTH) concentration greater than 500 pg/mL from screening to baseline
- Previous parathyroid interventions such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT)
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.
Duration - Up to 8 weeks
Participants receive daily oral doses of TS-172 or placebo while continuing their prescribed phosphate binders and hemodialysis.
Weekly visits for up to 8 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. Taisho Pharmaceutical Co., Ltd.
T
Taisho Director Taisho Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here