TS-172 for lowering high phosphate in adults on hemodialysis
Official title: A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Run by Taisho Pharmaceutical Co., Ltd. · NCT07285291 · Data updated 2026-11-12
This will test whether adding TS-172 to standard phosphate binders lowers blood phosphate in adults receiving thrice-weekly hemodialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | January 9, 2026 |
| Main results expected | December 22, 2026 |
| Study ends | December 29, 2026 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07285291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) on thrice-weekly hemodialysis for ≥12 weeks with serum phosphorus ≥5.5 and <10.0 mg/dL who are taking a stable dose of at least one phosphate binder are the intended candidates.
✕Probably not a fit
Patients with very high intact PTH (>500 pg/mL), those who previously had parathyroid interventions, people not on regular hemodialysis, or those with phosphorus outside the 5.5–<10.0 mg/dL range are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3, randomized, double-blind, placebo-controlled study compares daily TS-172 (20–60 mg) plus the patient's prescribed phosphate binder(s) versus placebo plus binder(s) in adults on maintenance hemodialysis. Eligible outpatients are ≥18 years old, have been on hemodialysis three times weekly for at least 12 weeks, and have serum phosphorus between 5.5 and <10.0 mg/dL with a stable phosphate-binder regimen. Key exclusions include very high intact PTH (>500 pg/mL) and prior parathyroid interventions. Enrollment and dosing occur at a Taisho Pharmaceutical selected site in Tokyo, Japan, with participants randomized to active or placebo arms under double-blind conditions.
Why it matters
Potential benefit: If effective, TS-172 could provide an additional oral option to help lower serum phosphate when used alongside existing phosphate binders in patients on hemodialysis.
How similar studies have gone: Other oral phosphate-lowering agents and combination approaches, including newer drugs like tenapanor, have shown phosphate reductions in dialysis populations, but TS-172 itself is being tested in phase 3 and is not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -3) 2. Patients aged \>=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of \>= 5.5 mg/dL and \< 10.0 mg/dL at Visit 1 (Week -3) 4. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3) Exclusion Criteria: 1. Patients with confirmed serum intact PTH concentration \> 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Where it's running
-
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Taisho Pharmaceutical Co., Ltd. Taisho Pharmaceutical Co., Ltd.
- Email: shu_chiken@taisho.co.jp
- Phone: 81-3-3985-1118
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term TS-172 treatment for high phosphate in adults on hemodialysis
This will test whether long-term TS-172 can safely lower blood phosphate in adults receiving hemodialysis.
-
TS-172 in high phosphorus levels for people on peritoneal dialysis
This study tests TS-172 to see if it helps lower phosphorus in adults on peritoneal dialysis who have high phosphorus levels.
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.