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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024331
Receipt No. 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 2019/01/28

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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
Email 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
Email sdoi@hiroshima-u.ac.jp

Sponsor
Institute Department of Nephrology,Hiroshima University
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027787

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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