CompletedPhase 3

A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Japan101 participantsStarted 2025-01-06

Plain-language summary

A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia

Age range18 Years

SexALL

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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 -4)
✓. Patients aged \>=18 years at the time of obtaining informed consent
✓. Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4)
✓. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL.

✕. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
✕. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
✕. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Achievement rate of the target serum phosphorus level

Timeframe: Week 8

NCT IDNCT06745531

SponsorTaisho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-13