UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000491 |
|---|---|
| Receipt number | 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 14:39:13 |
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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
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
Sponsor or person
Institute
Division of Nephrology Department of Medicine Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000595
