UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025113 |
|---|---|
| Receipt number | R000028811 |
| Scientific Title | Investigation of the clinical effect of hemodialysis using electrolyzed water |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2019/01/28 23:30:53 |
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Basic information
Public title
Investigation of the clinical effect of hemodialysis using electrolyzed water
Acronym
Investigation of the clinical effect of hemodialysis using electrolyzed water
Scientific Title
Investigation of the clinical effect of hemodialysis using electrolyzed water
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Iwatani |
Organization
Osaka National Hospital, NHO
Division name
Nephrology
Zip code
Address
2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL
06-6942-1331
hiro@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Iwatani |
Organization
Osaka National Hospital, NHO
Division name
Nephrology
Zip code
Address
2-1-14, Hoenzaka, Chuo-ku, Osaka, Japan
TEL
06-6942-1331
Homepage URL
hiro@onh.go.jp
Sponsor or person
Institute
Nephrology, Osaka National Hospital, NHO
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
