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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005452
Receipt No. R000006466
Scientific Title Plasma pentosidine is associated with cardiovascular events in hemodialysis patients.
Date of disclosure of the study information 2011/04/17
Last modified on 2011/04/15

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Basic information
Public title Plasma pentosidine is associated with cardiovascular events in hemodialysis patients.
Acronym Pentosidine and cardiovascular events in HD patients.
Scientific Title Plasma pentosidine is associated with cardiovascular events in hemodialysis patients.
Scientific Title:Acronym Pentosidine and cardiovascular events in HD patients.
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is well known that the high cardiovascular risk in hemodialysis patients can not be fully explained by traditional risk factors. Recently advanced glycation end products (AGEs) are accepted as potential cardiovascular risk factors. The aim of this study is to investigate whether the high plasma pentosidine levels, one of the AGEs, are related to high risk for cardiovascular events in hemodialysis patients.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to investigate the association between plasma pentosidine level and cardiovascular events in hemodialysis patients.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes cardiovascular event (myocardial infarction, angina pectoris, stroke)
Key secondary outcomes all cause and CVD mortality

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
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic renal failure on hemodialysis
Key exclusion criteria History of apparent cardiovascular disease ( angina pectoris, myocardial infarction, stroke).
Malignancy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuichi Furuya
Organization Iwata City Hospital
Division name Renal Division, Department of Internal Medicine
Zip code
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwata City Hospital
Division name Renal Division, Department of Internal medicine
Zip code
Address
TEL
Homepage URL
Email r-furuya@isis.ocn.ne.jp

Sponsor
Institute Iwata City Hospital
Institute
Department

Funding Source
Organization Iwata City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Shizuoka
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 磐田市立総合病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 17 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 Completed
Date of protocol fixation
2003 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 05 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
2011 Year 04 Month 01 Day

Other
Other related information Cardiovascular events(angina pectoris, myocardial infarction, stroke) were followed for 90 months in hemodialysis patients.

Management information
Registered date
2011 Year 04 Month 15 Day
Last modified on
2011 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006466

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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