UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021180 |
|---|---|
| Receipt number | R000023248 |
| Scientific Title | Examination of searching about the association between cerebrum, hippocampal atrophy / cerebral ischemic lesion and various atherosclerotic parameters in the chronic kidney disease patient |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2024/03/03 09:56:07 |
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Basic information
Public title
Examination of searching about the association between cerebrum, hippocampal atrophy / cerebral ischemic lesion and various atherosclerotic parameters in the chronic kidney disease patient
Acronym
Study on the CKD and relations of cerebral ischemia
Scientific Title
Examination of searching about the association between cerebrum, hippocampal atrophy / cerebral ischemic lesion and various atherosclerotic parameters in the chronic kidney disease patient
Scientific Title:Acronym
Study on the CKD and relations of cerebral ischemia
Region
| Japan |
Condition
Condition
Chronic kidney disease (Stage I-IV)
Classification by specialty
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I will search the degree of whole-brain and hippocampal atrophy, and the cerebral ischemia in the CKD patient before dialysis initiation.
Basic objectives2
Others
Basic objectives -Others
For searching about the cause of brain atrophy and ischemia, I will search those cause from the basic patient background such as age and gender, or relations with the renal function and various parameters associated from arteriosclerosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the cerebrum, the hippocampal atrophy ratio by VSRAD
Evaluation of the brain blood flow by the SPECT (123I-IMP)
Key secondary outcomes
An inspection about the item and anamnesis, relations with drugs to reflect an arteriosclerosis-related parameters
Difference in brain blood flow, brain atrophy in each CKD stage
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The CKD patient who visiting our outpatient unit of nephrology will have been administrated and agreed to examine brain MRI and brain blood flow scintigraphy from December, 2015 to December, 2018
Key exclusion criteria
The past history of the stroke or person with the paralysis (aftereffects)
Patient in acknowledgment of old infarction or cerebral hemorrhage that was clear by a brain MRI images.
The patient who cannot do the examination of cognitive function by visual impairment, a hearing loss or mental instability
Patient who cannot secure of intravenous line on the right arms (after operation of breast cancer)
Patient with thyroid disease
The patient who takes a sleep agent, regularly
iodoallergy
The patient who have an MRI taboo (e.g. the pacemaker insertion, claustrophobia), a study person will judge to be inappropriate as a study subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Maesato |
Organization
Shonan Kamakura General Hospital
Division name
Department of Nephrology, Immunology, and Vascular Medicine
Zip code
Address
Okamoto 1370-1, Kamakura, Kanagawa, 247-8533 Japan
TEL
+81-467-461717
kyoko.maesato@tokushukai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Maesato |
Organization
Shonan Kamakura General Hospital
Division name
Department of Nephrology, Immunology, and Vascular Medicine
Zip code
Address
Okamoto 1370-1, Kamakura, Kanagawa, 247-8533 Japan
TEL
+81-467-461717
Homepage URL
kyoko.maesato@tokushukai.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
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
湘南鎌倉総合病院（神奈川県）Shonan-Kamakura General Hospital(Kanagawa pref.)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A study participant is absent at present.
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
