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

Conditions: Hyperphosphatemia Patients on Hemodialysis

Sex: All

Ages: 18 Years – 79 Years

Phase: PHASE2

Enrollment: 150

Sponsor: Taisho Pharmaceutical Co., Ltd.

Location: Japan

Summary

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

Eligibility Criteria

Inclusion Criteria: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 consentPatients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)Exclusion Criteria: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.)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05699239). StuddyBuddy aggregates publicly available trial information.