UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029819
Receipt number R000034066
Scientific Title Exploration of the minimal time from fistula creation to first cannulation on the occurrence of a VA event
Date of disclosure of the study information 2017/11/04
Last modified on 2017/11/03 22:55:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Exploration of the minimal time from fistula creation to first cannulation on the occurrence of a VA event

Acronym

Minimal time from fistula creation to first cannulation

Scientific Title

Exploration of the minimal time from fistula creation to first cannulation on the occurrence of a VA event

Scientific Title:Acronym

Minimal time from fistula creation to first cannulation

Region

Japan


Condition

Condition

chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine more accurately the minimal time from fistula creation to first cannulation on the occurrence of a VA event (i.e., surgical revision, thrombectomy or percutaneous angioplasty) and VA patency

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary endpoint was the first occurrence of a VA event, which was defined as the composite of thrombectomy, surgical revision, or percutaneous transluminal angioplasty (PTA).

Key secondary outcomes

Functional primary patency


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) started maintenance HD therapy using a forearm autogenous radio-cephalic AVF during 1997-2008 at Nagoya City University Hospital,2) the AVF was constructed at Nagoya City University Hospital, and 3) age 20 years or more at initiation of HD, regardless of gender.

Key exclusion criteria

1) acute kidney injuries or rapidly progressive glomerulonephritis, 2) coronary or cerebrovascular events within the previous 6 months before initiation of HD, 3) serious systemic diseases, and 4) starting HD using a wrist (tabatiere region) AVF, AVG, silastic cannula external arteriovenous shunt, and temporary or long-term CVC.

Target sample size

210


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Graduate school of Medical Sciences

Division name

Division of Nephrology, Dialysis Center

Zip code


Address

1 Kawasumi, Mizuho-ku

TEL

81528538221

Email

m-fukuda@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Graduate school of Medical Sciences

Division name

Division of Nephrology, Dialysis Center

Zip code


Address

1 Kawasumi, Mizuho-ku

TEL

81528538221

Homepage URL


Email

m-fukuda@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

名古屋市立大学病院 (愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 04 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

No longer recruiting

Date of protocol fixation

2014 Year 06 Month 23 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2017 Year 10 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2017 Year 12 Month 01 Day

Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information

retrospective cohort study


Management information

Registered date

2017 Year 11 Month 03 Day

Last modified on

2017 Year 11 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034066


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name