UMIN-CTR Clinical Trial

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
Email	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
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	Niigata University Graduate School of Medical and Dental Sciences
Address	1-757, Asahimachi-dori, Chuo-ku
Tel	0252272200
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014998