UMIN-CTR Clinical Trial

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
Email	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
Email	ysato@fc.miyazaki-u.ac.jp

Sponsor
Institute	Dialysis Division, University of Miyazaki Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006128