UMIN-CTR Clinical Trial

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
Last 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
Email

Public contact
1st 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
Email	fybnt014@yahoo.co.jp

Sponsor
Institute	Department of Nephrology and Hypertension, St. Marianna University School of Medicine
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004842