UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005452 |
|---|---|
| Receipt number | 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 18:24:33 |
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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
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
r-furuya@isis.ocn.ne.jp
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006466
