Phase 3 Study of Oral TS-172 for Treating High Blood Phosphorus in Adults on Hemodialysis

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.

A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis