UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the clinical effect of hemodialysis using electrolyzed water
Title of the study (Brief title)	Investigation of the clinical effect of hemodialysis using electrolyzed water
Region	Japan

Condition
Condition	renal failure requiring hemodialysis (HD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether or not there is a difference in the concentration or the temporal change of the exhaled hydrogen gas between the patients on conventional HD and those on HD using electrolyzed water.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	exhaled hydrogen
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	hemodialysis using electrolyzed water, one session
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	inpatients undergoing HD in our hospital
Key exclusion criteria	pregnant patients
Target sample size	40

Research contact person
Name of lead principal investigator	Hirotsugu Iwatani
Organization	Osaka National Hospital, NHO
Division name	Nephrology
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL	06-6942-1331
Email	hiro@onh.go.jp

Public contact
Name of contact person	Hirotsugu Iwatani
Organization	Osaka National Hospital, NHO
Division name	Nephrology
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL	06-6942-1331
Homepage URL
Email	hiro@onh.go.jp

Sponsor
Institute	Nephrology, Osaka National Hospital, NHO
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 11 Month 09 Day
Anticipated trial start date	2016 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028811