臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 04, 2025
Last modified on	Feb. 04, 2026
Trial ID	jRCT2031250548

Scientific Title	A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
Public Title	A phase 3 study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders

Contact for Scientific Queries	Name	Mita Seiji
	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	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 05, 2026
Actual date of first enrollment		Jan. 09, 2026
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel 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 -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 at Visit 1 (Week -3) 4. 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 -3)
	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.)
	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 8 weeks with phosphate binders
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Achievement rate of the target serum phosphorus level at Week 8
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
Date of approval	Dec. 08, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 04, 2026	(this page)	Changes
2	Jan. 08, 2026	Detail	Changes
1	Dec. 04, 2025	Detail

List of change history