臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 07, 2025
Last modified on	Mar. 07, 2025
Trial ID	jRCTs061240132

Scientific Title	Exploratory interventional study on the safety of hydrogen inhalation in patients on maintenance hemodialysis.
Public Title	Study on the safety of hydrogen inhalation in hemodialysis patients.

Contact for Scientific Queries	Name	Shibuya Masaki
	Affiliation	Yamaguchi University Hospital
	Address	1-1-1, Minamikogushi, Ube-shi, Yamaguchi-ken
	Telephone	+81-836-22-2248
	E-mail	mshibuya@yamaguchi-u.ac.jp
Contact for Public Queries	Name	Shibuya Masaki
	Affiliation	Yamaguchi University Hospital
	Address	1-1-1, Minamikogushi, Ube-shi, Yamaguchi-ken
	Telephone	+81-836-22-2248
	E-mail	mshibuya@yamaguchi-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 07, 2025
Target sample size		10
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) Patients who have been on maintenance haemodialysis (including haemodialysis and haemodiafiltration) for at least 3 months. (2) Patients who are at least 18 years of age at the time of consent . (3) Gender Not applicable. (4) Inpatient or outpatient Not applicable. (5) Patients who have been fully informed of the study and have given their voluntary written consent based on full understanding.
	Exclusion Criteria	(1) Patients with a history of or complicated with malignant tumours. However, patients with a history of malignant tumours who are untreated and have not relapsed for more than 5 years at the time of obtaining consent may be included. (2) Patients complicated with unstable angina or non-compensated heart failure. (3) Patients complicated with cirrhosis or liver failure. (4) Patients who require oxygen inhalation during dialysis. (5) Patients with frequent hypotension during dialysis (6)Patients who are judged to be inappropriate as research subjects by the principal investigator (co-principal investigator).
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic kidney disease G5D (under hemodialysis)
Intervention(s)		Hydrogen inhalation (250 mL/min) for 24 weeks during haemodialysis (3 times a week for approx. 4 hr/treatment).
Health Condition(s) Keyword		CKDG5D, Hemodialysis
Intervention(s) Keyword		Hydrogen inhalation
Health Condition(s) Code		C12.050.351.968.419.780.750.500
Intervention(s) Code		D01.268.406
Primary Outcome(s)		Safety (adverse events)
Secondary Outcome(s)		Relationship between hydrogen dosage and hydrogen blood concentration, expiratory gas analysis and ABI/CAVI, effect on anemia, effect on fatigue

Source of Monetary Support / Secondary Sponsor	Doctors Man Co. Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Yamaguchi University Certified Review Board
Address	1-1-1 Minamikogushi,Ube-shi Yamaguchi-ken,755-8505 Japan, Yamaguchi
Telephone	+81-836-22-2428
E-Mail	yrinsyo@yamaguchi-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 15, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none