UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005160 |
|---|---|
| Receipt number | R000006128 |
| Scientific Title | Miyazaki Dialysis Cohort Study (MID study) |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2021/09/07 10:16:48 |
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Basic information
Public title
Miyazaki Dialysis Cohort Study (MID study)
Acronym
Miyazaki Dialysis Cohort Study (MID study)
Scientific Title
Miyazaki Dialysis Cohort Study (MID study)
Scientific Title:Acronym
Miyazaki Dialysis Cohort Study (MID study)
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the influence of blood pressure control to cardiovascular events on hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
A prospective cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The influence of blood pressure (supine and upright position) before and after hemodialysis session upon the cardiovascular events and mortality in hemodialysis patients
Key secondary outcomes
The risk factors of cardiovascular events in hemodailysis patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hemodialysis patietns
Key exclusion criteria
The patients of acute renal failure
The hospitalized patients
The patients who do not agree with this study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Fujimoto |
Organization
University of Miyazaki
Division name
Department of Hemovascular Medicine and Artificial Organs
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985-85-9848
fujimos@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Sato |
Organization
University of Miyazaki
Division name
Dialysis Division
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985-85-0872
Homepage URL
ysato@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
Dialysis Division, University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
宮崎大学医学部附属病院（宮崎県）
(University of Miyazaki Hospital)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | 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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Over than 1,500 patients on chronic hemodialysis were enrolled this study.
Management information
Registered date
| 2011 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006128
