UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033153 |
|---|---|
| Receipt number | R000037807 |
| Scientific Title | The feasibility of arteriovenous fistula combined with venous superficialization (AVF-VS) as an alternative hemodialysis vascular access (VA) |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2019/12/09 15:12:28 |
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Basic information
Public title
The feasibility of arteriovenous fistula combined with venous superficialization (AVF-VS) as an alternative hemodialysis vascular access (VA)
Acronym
The feasibility of arteriovenous fistula combined with venous superficialization (AVF-VS) as an alternative hemodialysis vascular access (VA)
Scientific Title
The feasibility of arteriovenous fistula combined with venous superficialization (AVF-VS) as an alternative hemodialysis vascular access (VA)
Scientific Title:Acronym
The feasibility of arteriovenous fistula combined with venous superficialization (AVF-VS) as an alternative hemodialysis vascular access (VA)
Region
| Japan |
Condition
Condition
End-stage renal disease requiring maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility of an alternative VA utilizing a combined procedure of conventional arteriovenous fistula (AVF) creation and superficialization of inaccessible arterialized vein for maximizing the autologous venous availability in patients requiring maintenance hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary patency
Key secondary outcomes
Secondary patency
Incidence of postoperative complication
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) Patients who underwent AVF-VS procedure
2) Patients who provided written informed consent to participate in this study
Key exclusion criteria
Patients judged as unsuitable for participating in this study by the attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nanami |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Kidney and Dialysis
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6521
m-nanami@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nanami |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Kidney and Dialysis
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6521
Homepage URL
m-nanami@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Organization of Occupational Health and Safety, Kansai Rosai Hospital
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
兵庫医科大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center prospective study
Management information
Registered date
| 2018 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037807
