UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005070 |
|---|---|
| Receipt number | R000006033 |
| Scientific Title | Relation between vascular endothelial cell function and vascular access failure in dialysis patients |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2011/02/12 15:52:41 |
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Basic information
Public title
Relation between vascular endothelial cell function and vascular access failure in dialysis patients
Acronym
Relation between vascular endothelial cell function and vascular access failure
Scientific Title
Relation between vascular endothelial cell function and vascular access failure in dialysis patients
Scientific Title:Acronym
Relation between vascular endothelial cell function and vascular access failure
Region
| Japan |
Condition
Condition
dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relation between vascular endothelial cell function and vascular access failure in dialysis patients is clarified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
primary patency of vascular access
Key secondary outcomes
PTA assisted patency of vascular access
Ultrasound monitoring of vascular access
vascular endothelial cell function
pathologic assessment of artery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who made vascular access in St. Marianna University School of Medicine hospital.
Key exclusion criteria
1.Case who doesn't obtain agreement.
2.Patient who judged it is inappropriate.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Miyamoto |
Organization
St. Marianna university school of medicine
Division name
Division of nephrology and hypertension
Zip code
Address
2-16-1 sugao miyamae-ku kawasaki kanagawa japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahito Miyamoto |
Organization
St. Marianna university school of medicine
Division name
Division of nephrology and hypertension
Zip code
Address
2-16-1 sugao miyamae-ku kawasaki kanagawa japan
TEL
044-977-8111
Homepage URL
m2miyamoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna university school of medicine
Organization
Division
Category of Funding Organization
Other
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
聖マリアンナ医科大学（大学院）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Observation item
Primary patency of vascular access
PTA assisted patency of vascular access
Ultrasound monitoring of vascular access
vascular endothelial cell function
pathologic assessment of artery
Management information
Registered date
| 2011 | Year | 02 | Month | 12 | Day |
Last modified on
| 2011 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006033
