RecruitingPhase 3

A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Japan300 participantsStarted 2025-12-01

Plain-language summary

A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. Patients aged ≥18 years at the time of obtaining informed consent
✓. 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)
✓. 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)

✕. Patients with confirmed serum intact PTH concentration \>500 pg/mL at Visit 1 (Week -2)
✕. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Incidence of adverse events

Timeframe: Up to 26 weeks or up to 52 weeks

NCT IDNCT07285304

SponsorTaisho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

Taisho Pharmaceutical Co., Ltd.