臨床研究等提出・公開システム

Scientific Title	A phase 3 long-term study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders
Public Title	A long-term study of TS-172 in hyperphosphatemia patients on hemodialysis

Contact for Scientific Queries	Name	Seiji Mita
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp
Contact for Public Queries	Name	Development Management Development Headquarters
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	TOSHIMA-KU,TOKYO 170-8633 JAPAN
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 01, 2025
Actual date of first enrollment		Dec. 01, 2025
Target sample size		300
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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 -2) 2. Patients aged >=18 years at the time of obtaining informed consent 3. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -2) 4. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and <= 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)
	Exclusion Criteria	'1. Patients with confirmed serum intact PTH concentration >500 pg/mL at Visit 1 (Week -2) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hyperphosphatemia
Intervention(s)		Oral administration of TS-172 20~60 mg/day for 26 weeks or 52 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Adverse event
Secondary Outcome(s)

Primary Sponsor	Taisho Pharmaceutical Co., LTD.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokushukai Group Institutional Review Board
Address	1-3-1, Kudan-minami, Chiyoda-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3263-4801
E-Mail	irb@mirai-iryo.com
Approval Status	Approval
Date of approval	Nov. 14, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history