Phase 3 Study of TS-172 With Phosphate Binders in Adults on Hemodialysis for High Blood Phosphorus

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.

A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders