Long-term TS-172 treatment for high phosphate in adults on hemodialysis
Official title: A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Run by Taisho Pharmaceutical Co., Ltd. · NCT07285304 · Data updated 2026-11-12
This will test whether long-term TS-172 can safely lower blood phosphate in adults receiving hemodialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07285304 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with chronic kidney disease on thrice-weekly hemodialysis for ≥12 weeks who have serum phosphorus between 3.5 and 7.0 mg/dL and a stable phosphate binder regimen.
✕Probably not a fit
Patients with very high intact PTH (>500 pg/mL), prior parathyroid procedures, unstable phosphate-binder dosing, or who cannot attend the Tokyo site are unlikely to benefit from this trial.
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 interventional trial gives TS-172 to adults with chronic kidney disease on thrice-weekly hemodialysis to study long-term safety and efficacy for hyperphosphatemia. Eligible participants must be ≥18 years, on hemodialysis (HD or HDF) three times per week for at least 12 weeks, taking a stable phosphate binder regimen, and have serum phosphorus of 3.5–7.0 mg/dL. Key exclusions include intact PTH >500 pg/mL or prior parathyroid interventions. The trial is sponsored by Taisho Pharmaceutical and conducted at a company-selected site in Tokyo, Japan.
Why it matters
Potential benefit: If successful, TS-172 could offer a safe long-term option to help control serum phosphate in people on hemodialysis.
How similar studies have gone: Other oral phosphate binders have successfully lowered serum phosphate in dialysis patients, but TS-172's long-term safety and efficacy are not yet established.
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 -2) 2. Patients aged ≥18 years at the time of obtaining informed consent 3. 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 -2) 4. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1) Exclusion Criteria: 1. Patients with confirmed serum intact PTH concentration \>500 pg/mL at Visit 1 (Week -2) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Where it's running
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Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: 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.
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TS-172 for lowering high phosphate in adults on hemodialysis
This will test whether adding TS-172 to standard phosphate binders lowers blood phosphate in adults receiving thrice-weekly 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.