Phase 3 Long-Term Study of Oral TS-172 for People with Hyperphosphatemia on Hemodialysis Using Phosphate Binders

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 drugs 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.

A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis