UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the operation and PTA on the patency for vascular access in Tanakakitanoda
Title of the study (Brief title)	VACT study
Region	Japan

Condition
Condition	vascular access failure
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of the operation and PTA on the patency for vascular access
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) vascular access failure: occlusion of vascular access or intervention for the failure 2) cardiovascular events and death: stroke, coronary artery disease, peripheral artery disease, and admission for heart failure
Key secondary outcomes	1) all-cause death 2) all-cause admission

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Cases of operation and PTA of vascular access in the Hospital of Hyogo College of Medicine and Tanakakitanoda Hospital 2) Patients with the informed consent to this study by themselves
Key exclusion criteria	Patients judged as unsuitable for participanting in this study by the attending physician
Target sample size	1000

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798456521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Yukiko Hasuike
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798456521
Homepage URL
Email	cherry39@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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），田仲北野田病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 05 Month 16 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Investigate the effects of clinical factors of chronic kidney disease on vascular access failure and cardiovascular events in hemodialzed patients

Management information
Registered date	2014 Year 05 Month 15 Day
Last modified on	2017 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015822