臨床研究等提出・公開システム

Date of registration	Jan. 21, 2022
Last modified on	June. 02, 2023
Trial ID	jRCT2031210570

Scientific Title	AYD001 Phase III Clinical Trial (AYD001/CT1)
Public Title	AYD001 Phase III Clinical Trial (AYD001/CT1)

Contact for Scientific Queries	Name	Asaoka Kuniharu
	Affiliation	Yoshindo Inc.
	Address	3697-8, Fuchumachi Haginoshima, Toyama-shi, Toyama
	Telephone	+81-76-465-7782
	E-mail	kaihatu@yoshindo.co.jp
Contact for Public Queries	Name	R&D Department
	Affiliation	Yoshindo Inc.
	Address	3697-8, Fuchumachi Haginoshima, Toyama-shi, Toyama
	Telephone	+81-76-465-7782
	E-mail	kaihatu@yoshindo.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 21, 2022
Actual date of first enrollment		Nov. 01, 2021
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients undergoing hemodialysis for 3 to 5 hours per session, 3 times a week at the time of informed consent. (2) Patients aged 20 to less than 90 years old. (3) Patients providing written informed consent about participation in this clinical study
	Exclusion Criteria	(1) Patients within 26 weeks of initiating hemodialysis at the time of informed consent (2) Patients with severe hepatic function impairment (3) Patients with severe heart disease (4) Patients with severe respiratory disorder
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with chronic renal failure undergoing hemodialysis
Intervention(s)		At the time of use, add 26 volumes of water to 1 volume of Agent B of AYD001 to dilute it, and add 1 volume of Agent A to 34 volumes of this diluted solution to dilute it. The dose varies depending on the dialysis time, but usually 150 to 300 L of perfusate is used at a time.
Primary Outcome(s)		Correction of azotemia (BUN, Cre, and UA)

Primary Sponsor	Yoshindo Inc.

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	+81-3-6665-0572
Approval Status	Approval
Date of approval	Sept. 22, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 02, 2023	(this page)	Changes
1	Jan. 21, 2022	Detail

List of change history