UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012839 |
|---|---|
| Receipt number | R000014998 |
| Scientific Title | Functional abnormalities of macrophages in patients with CKD |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2022/01/19 12:09:55 |
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Basic information
Public title
Functional abnormalities of macrophages in patients with CKD
Acronym
CKD and macrophages
Scientific Title
Functional abnormalities of macrophages in patients with CKD
Scientific Title:Acronym
CKD and macrophages
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic kidney disease (CKD) is one of most serious risk factors for cardiovascular disease. One of the reasons is thought to be functional abnormalities of macrophages in atherosclerotic lesion. The aim of this study is to examine macrophage function in patients with CKD.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate that macrophage function in patients with CKD as compare to those with normal kidney function.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age is not less than 20 and less than 90 years old
Key exclusion criteria
Age is less than 20 and not less than 90 years old.
Patient during pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
951-8510
Address
1-757 Ashahimachi-dori, Chuou-ku, Niigata, 951-8510, JAPAN
TEL
0252270436
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuou-ku, Niigata, 951-8510Japan
TEL
0252270436
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-dori, Chuo-ku
Tel
0252272200
yamamots@med.niigata-u.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
| 2014 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Peripheral monocyte-derived macrophages from non-CKD, CKD stage 3, 4, 5, or 5D patients will be reacted with lipoprotein or inflammatory cytokines.
Management information
Registered date
| 2014 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014998
