Long-term TS-172 treatment for high phosphate in adults on hemodialysis
A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
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 |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT07285304 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tokyo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.