UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007470 |
|---|---|
| Receipt number | R000008813 |
| Scientific Title | Osaka Dialysis Complication Study |
| Date of disclosure of the study information | 2012/03/08 |
| Last modified on | 2020/03/25 19:56:35 |
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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
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
t-shoji@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Metabolism, Endocrinology and Molecular Medicine & Department of Vascular Medicine, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 |
