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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007470
Receipt No. R000008813
Scientific Title Osaka Dialysis Complication Study
Date of disclosure of the study information 2012/03/08
Last modified on 2019/09/17

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Basic information
Public title Osaka Dialysis Complication Study
Acronym ODCS
Scientific Title Osaka Dialysis Complication Study
Scientific Title:Acronym ODCS
Region
Japan

Condition
Condition Hemodialysis patients
Classification by specialty
Endocrinology and Metabolism Nephrology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prevalence, decline and risk factors of cognitive impairment in hemodialysis patients (primary).
Basic objectives2 Others
Basic objectives -Others To examine the association of cognitive impairment with other complications in hemodialysis patients (secondary).
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function
Key secondary outcomes Cardiovascular disease, Activity of daily living

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Hemodialysis patients
2) Men and women of 20 years old or older
3) Those who or whose family give informed consent
Key exclusion criteria 1) Hospitalized patients due to acute or severe illness
2) Those who are judged inappropriate by an attending physician.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Inaba
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3805
Email inaba-m@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Shoji
Organization Osaka City University Graduate School of Medicine
Division name Department of Vascular Medicine
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3930
Homepage URL
Email t-shoji@med.osaka-cu.ac.jp

Sponsor
Institute Department of Metabolism, Endocrinology and Molecular Medicine & Department of Vascular Medicine, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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 Ethical Committee of Osaka City University Graduate School of Medicine
Address Abeno Medix 6th floor, 1-2-7 Asahi-machi, Abeno-Ku, Osaka
Tel 06-6645-3456
Email irb@med.osaka-cu.ac.jp

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
2012 Year 03 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 1696
Results
1) At baseline, cognitive function was evaluated in 1228 out of 1696 participants. 
Results date posted
2019 Year 09 Month 17 Day
Results Delayed
Delay expected
Results Delay Reason Due to delay of compiling and analysis of data.
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
2011 Year 11 Month 29 Day
Date of IRB
2012 Year 01 Month 11 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Main measurements: Clinical background, cognitive function, complications, ability of daily living, quality of life, physical findings, clinical laboratory data, medications

Management information
Registered date
2012 Year 03 Month 08 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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