UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009233 |
|---|---|
| Receipt number | R000010843 |
| Scientific Title | Chronic Kidney Disease and Vascular Cognitive Impairment |
| Date of disclosure of the study information | 2012/12/14 |
| Last modified on | 2016/11/04 13:28:20 |
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Basic information
Public title
Chronic Kidney Disease and Vascular Cognitive Impairment
Acronym
CKD-VCI
Scientific Title
Chronic Kidney Disease and Vascular Cognitive Impairment
Scientific Title:Acronym
CKD-VCI
Region
| Japan |
Condition
Condition
Pre-dialysis chronic kidney disease
Classification by specialty
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the roles of subclinical cerebrovascular disease in cognitive impairment in patients with chronic kidney disease
Basic objectives2
Others
Basic objectives -Others
To examine the roles of humoral factors including uremic toxins in cognitive impairment in patients with chronic kidney disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Cognitive function
(2) Subclinical cerebrovascular disease by MRI
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with CKD but not yet receiving renal transplantation or dialysis treatment (Pre-dialysis CKD)
2) Out-patients or In-patients of Osaka City University Hospital
3) Patients of 50 years old or older
4) Patients who gave written informed consent
Key exclusion criteria
1) Patients due to acute or severe illness
2) Patients who are receiving medication for dementia
3) Those who are judged inappropriate by an attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Inaba |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3806
inaba-m@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Shoji |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Vascular Medicine
Zip code
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
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
| 2012 | Year | 12 | Month | 14 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 31 | Day |
Last follow-up date
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 | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010843
