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

Taisho Pharmaceutical Co., Ltd.326 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

326

Conditions

Hyperphosphatemia Patients on Hemodialysis

Interventions

TS-172 10mg bidDRUG

oral administration of TS-172 10 mg bid

TS-172 30mg bidDRUG

oral administration of TS-172 30 mg bid

TS-172 60mg bidDRUG

oral administration of TS-172 60 mg bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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) 2. Patients aged ≥18 to \<80 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4) 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) to Visit 5 (Week 0) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Outcomes

Primary Outcomes

Change from baseline in serum concentration of phosphorus

Time frame: Week 4

Secondary Outcomes

Achievement ratio of patients with the target serum concentration of phosphorus

Time frame: Up to Week 4

Concentration of corrected serum calcium

Time frame: Up to Week 4

Serum calcium times phosphorus product

Time frame: Up to Week 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.