UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004251 |
|---|---|
| Receipt number | R000004842 |
| Scientific Title | Effect of Tranilast on restenosis of Arteriovenous Fistulas for Hemodialysis. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2019/04/01 20:39:47 |
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Basic information
Public title
Effect of Tranilast on restenosis of Arteriovenous Fistulas for Hemodialysis.
Acronym
Effect of Tranilast on restenosis of Arteriovenous Fistulas for Hemodialysis.
Scientific Title
Effect of Tranilast on restenosis of Arteriovenous Fistulas for Hemodialysis.
Scientific Title:Acronym
Effect of Tranilast on restenosis of Arteriovenous Fistulas for Hemodialysis.
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether tranilast reduces recurrent stenosis after percutaneous transliminal angioplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is number of PTA times for one year after patients receive tranilast.
Key secondary outcomes
The secondary outcome is failure of the fistula or graft determined by ultrasound.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
It is the crossover trials which is receving tranilast for one year and non-medication for one year.
Interventions/Control_2
It is the crossover trials which is receving tranilast for one year and non-medication for one year.
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
The patients who visit our hospital at regular intervals and undergo PTA are recruited.
Key exclusion criteria
The exclusion criteria are follows;
1) newly receiving the antiplatelet agent
or antithrombocytic agent or anticoagulant agent or anticoagulant agent or vasodilating age within three monthes
2) drug allergy to tranilast
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
044-977-8111
Homepage URL
fybnt014@yahoo.co.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, St. Marianna University School of Medicine
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
聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | 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
| 2010 | Year | 09 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004842
