臨床研究等提出・公開システム

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

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 Headquarters Development Management
	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	Complete

Anticipated date of first enrollment		Jan. 31, 2023
Actual date of first enrollment		Feb. 08, 2023
Target sample size		150
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 -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.)
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hyperphosphatemia
Intervention(s)		Oral drug administration of TS-172 (10 mg bid, 30 mg bid, 60 mg bid or 20 mg tid) for 4 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in serum concentration of phosphorus at Week 4
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	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5213-0028
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval	Jan. 23, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05699239
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history