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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012839
Receipt No. R000014998
Scientific Title Functional abnormalities of macrophages in patients with CKD
Date of disclosure of the study information 2014/01/15
Last modified on 2019/01/17

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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
Middle name
Last name Suguru Yamamoto
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Clinical Nephroscience
Zip code
Address 1-757 Ashahimachi-dori, Chuou-ku, Niigata, 951-8510, JAPAN
TEL 0252270436
Email yamamots@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Yamamoto
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Clinical Nephroscience
Zip code
Address 1-757 Asahimachi-dori, Chuou-ku, Niigata, 951-8510Japan
TEL 0252270436
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2014 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 15 Day
Last follow-up date
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
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014998

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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