TS-172 in high phosphorus levels for people on peritoneal dialysis
Official title: An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis
Run by Taisho Pharmaceutical Co., Ltd. · NCT07548853 · Data updated 2026-11-12
This study tests TS-172 to see if it helps lower phosphorus in adults on peritoneal dialysis who have high phosphorus levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | May 13, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07548853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with chronic kidney disease on peritoneal dialysis and hyperphosphatemia who are on a stable phosphate binder regimen.
✕Probably not a fit
Patients whose phosphorus levels do not rise during the study or who experience adverse effects may not benefit from TS-172.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3, open-label, single-arm trial evaluating TS-172 at 20–60 mg/day in adults with hyperphosphatemia undergoing peritoneal dialysis. Eligible participants have stable phosphate binder therapy and a recent rise in serum phosphorus to 5.5–9.9 mg/dL. The study monitors changes in phosphorus levels through visits at Week -4, Week -2, Week -1, and Week 0, focusing on safety and efficacy in a real-world outpatient setting. Taisho Pharmaceutical Co., Ltd. leads the trial at a Taisho Selected Site in Tokyo, with no listed collaborators.
Why it matters
Potential benefit: If successful, TS-172 could help reduce high phosphorus levels in peritoneal dialysis patients, potentially lowering related health risks.
How similar studies have gone: The document does not provide data on prior studies of TS-172; this appears to be a novel or less-established approach for this indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving peritoneal dialysis (CAPD or APD) at least 12 weeks prior to Visit 1 (Week -4) 2. Patients aged \>= 18 years at the time of obtaining informed consent 3. Patients who are receiving at least one phosphate binder and whose dosing regimen for all phosphate-lowering agents (phosphate binder and tenapanor hydrochloride) has been unchanged during the last 4 weeks prior to Visit 1 (Week -4). 4. Patients with serum phosphorus concentration of \>= 3.5 mg/dL and =\< 7.0 mg/dL at Visit 1 (Week -4) 5. Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL. Exclusion Criteria: 1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 4 (Week 0) 2. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (Week -1) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Where it's running
-
Taisho Selected Site
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Taisho Pharmaceutical Co., Ltd.
- Email: shu_chiken@taisho.co.jp
- Phone: 81-3-3985-1118
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.