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

Last updated: February 26, 2025
Sponsor: Taisho Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

TS-172 20~60 mg/day

Clinical Study ID

NCT06745531
TS172-03-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receivinghemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)

  2. Patients aged >=18 years at the time of obtaining informed consent

  3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL atVisit 1 (Week -4)

  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.

Exclusion

Exclusion Criteria:

  1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)

  2. Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -3) toVisit 4 (Week -1)

  3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 06, 2025
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Taisho Pharmaceutical Co., Ltd selected site

    Tokyo,
    Japan

    Active - Recruiting

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