UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024331 |
|---|---|
| Receipt number | R000027787 |
| Scientific Title | Comparison of balloon inflation time in Angioplasty for failed aRteriovenous fistula among hemodialysis Patients - A multicenter, prospective, randomized, controlled trial - |
| Date of disclosure of the study information | 2016/10/10 |
| Last modified on | 2024/04/12 13:21:58 |
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Basic information
Public title
Comparison of balloon inflation time in Angioplasty for failed aRteriovenous fistula among hemodialysis Patients
- A multicenter, prospective, randomized, controlled trial -
Acronym
CARP trial
Scientific Title
Comparison of balloon inflation time in Angioplasty for failed aRteriovenous fistula among hemodialysis Patients
- A multicenter, prospective, randomized, controlled trial -
Scientific Title:Acronym
CARP trial
Region
| Japan |
Condition
Condition
Vascular access stenosis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect on the patency rate of extended time for the vascular access stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The 6-month patency rate after baloon angioplasty
Key secondary outcomes
Primary success rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balloons are inflated to the 0 seconds
Interventions/Control_2
Balloons are inflated to the 30 seconds
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
Patients who underwent vascular access failure and satisfy the indication criteria for PTA established by the Japanese Society for Dialysis Therapy.
Key exclusion criteria
Patients1 who underwents contrast agent allergy,severe heart failure, and pregnants.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MASSAKI, Takao |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-ku,Hiroshima
TEL
082-257-1506
masaki4221@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | DOI.Shigehiro |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-ku,Hiroshima
TEL
082-257-1506
Homepage URL
sdoi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Nephrology,Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
広島大学病院(広島県)、尾道クリニック(広島県)、中央内科クリニック(広島県)、博愛クリニック(広島県)、双樹クリニック(広島県)、JA尾道総合病院（広島県）、呉共済病院（広島県）、呉医療センター（広島県）、県立広島病院（広島県）、原田病院（広島県）、JA広島総合病院（広島県）、土谷総合病院（広島県）、東広島医療センター（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 10 | 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
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027787
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
