CompletedPhase 2

A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Japan326 participantsStarted 2023-02-08

Plain-language summary

A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis

Age range18 Years – 79 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 to \<80 years at the time of obtaining informed consent
✓. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

✕. 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 5 (Week 0)
✕. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Change from baseline in serum concentration of phosphorus

Timeframe: Week 4

NCT IDNCT05699239

SponsorTaisho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-26