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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000491
Receipt No. R000000595
Scientific Title Impact of inflammation, oxidative stress and anti-vascular calcification factors on progress of atherosclerosis in end-stage renal disease patients
Date of disclosure of the study information 2006/09/19
Last modified on 2014/09/29

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Basic information
Public title Impact of inflammation, oxidative stress and anti-vascular calcification factors on progress of atherosclerosis in end-stage renal disease patients
Acronym Study for atherosclerosis-associated factors in end-stage renal disease patients
Scientific Title Impact of inflammation, oxidative stress and anti-vascular calcification factors on progress of atherosclerosis in end-stage renal disease patients
Scientific Title:Acronym Study for atherosclerosis-associated factors in end-stage renal disease patients
Region
Japan

Condition
Condition End-stage renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Atherosclerotic cardiovascular disease (CVD) is characterized by accumulation of lipids, inflammatory cells (macrophages, lymphocytes and smooth muscles cells) and extracellular matrix in the plaque, and inflammation plays a central role in the atherogenetic process. Moreover end-stage renal disease (ESRD) patients present a characteristic atherogenic state as mineral bone disorder and oxidative stress enhancement. Those states may induce high prevalence of CVD events, and CVD contributes significantly to the markedly increased mortality in these patients. The purpose of the study is to estimate how inflammation, oxidative stress and vascular calcification associated factors affect progress of atherosclerosis in ESRD patients.
Basic objectives2 Others
Basic objectives -Others The purpose of the study is to assess influence of classical risk factors of atherosclerosis(hypertension, lipid abnormality etc), inflammation(interleulin-6, high sensitive C-reactive protein), oxidative stress(ox LDL-C, myeloperoxidase), vascular calcification associated factors(fetuin-A, osteoprotegerin,FGF23), endothelial progenitor cell etc. on atherosclerosis in MHD patients. Moreover influence of medication on the progress of atherosclerosis.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes In the cross-sectional and prospective studies (n=600), impact of inflammation, oxidative stress vascular calcification associated factors on atherosclerosis progress.
Key secondary outcomes Assessment of nutritional state and factors which associated with atherosclerosis

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction
2) Expected survival time is more than 6 months
3) Aged 20 years over
4) Fully informed consent was obtained
Key exclusion criteria 1) Malignancy
2) Malnutrition
3) Active inflammatory or infectious disease
4)) Abdominal ascites or pleural effusion
5) Pregnancy
6) Judged inappropriate for this study by the physicians
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Honda
Organization Showa University School of Medicine
Division name Division of Nephrology Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Honda
Organization Showa University School of Medicine
Division name Division of Nephrology Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Division of Nephrology Department of Medicine Showa University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology Department of Medicine Showa University School of Medicine
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
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
2006 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information Influence of clinical parameters on cumulative survival, cross-sectional and prospective studies

Management information
Registered date
2006 Year 09 Month 19 Day
Last modified on
2014 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000595

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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