TS-172 for lowering high phosphate in adults on hemodialysis

A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

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
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tokyo)
• Trial ID: NCT07285291 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Tokyo

• Taisho Pharmaceutical Co., Ltd selected site — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Taisho Pharmaceutical Co., Ltd. Taisho Pharmaceutical Co., Ltd.

Conditions Hyperphosphatemia Patients on Hemodialysis