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

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 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

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

Value
https://center6.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