Phase 3 Study of Oral TS-172 for Treating High Phosphorus in Adults on Peritoneal Dialysis

What this Trial Is About

This clinical trial studies patients with hyperphosphatemia who are undergoing peritoneal dialysis due to chronic kidney disease. It is an open-label, single-arm Phase 3 study sponsored by Taisho Pharmaceutical Co., Ltd., aiming to evaluate the effect of TS-172 on lowering serum phosphorus levels. The trial focuses on patients who have been on peritoneal dialysis for at least 12 weeks and are currently receiving phosphate binders with stable dosing. Participants receive oral TS-172 at doses ranging from 20 to 60 mg per day. The study runs through multiple visits starting from a screening period to treatment and evaluation up to Week 16. The primary measurement is the rate of achieving the target serum phosphorus level at Week 8. Secondary measures include changes in serum phosphorus, corrected serum calcium, and serum calcium-phosphorus product over 16 weeks. During the study, participants undergo regular blood tests to monitor phosphorus and calcium levels. The researchers track adherence to medication and evaluate biochemical changes. The study includes safety monitoring and follow-up assessments throughout the 16-week observation period. Participants involvement spans from initial screening through treatment and evaluation phases, concluding with the primary outcome assessment at Week 8 and extended follow-up to Week 16.

A Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis