A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Last updated: June 5, 2025
Sponsor: Taisho Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

TS-172

Placebo

Clinical Study ID

NCT06745518
TS172-02-03
  • Ages > 18
  • All Genders

Study Summary

A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

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 -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 atVisit 1 (Week -3)

  4. Patients who have been prescribed at least one phosphate binder within the approveddosage, and the prescribed drug and dosage regimen should have been unchanged duringthe last 2 weeks prior to Visit 1 (Week -3)

Exclusion

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.)

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: TS-172
Phase: 2
Study Start date:
January 06, 2025
Estimated Completion Date:
August 26, 2025

Connect with a study center

  • Taisho Pharmaceutical Co., Ltd selected site

    Tokyo,
    Japan

    Site Not Available

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