UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043634
Receipt number R000049825
Scientific Title Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex
Date of disclosure of the study information 2021/04/01
Last modified on 2021/09/15 10:15:17

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Basic information

Public title

Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex

Acronym

Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex

Scientific Title

Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex

Scientific Title:Acronym

Analysis of association between ANCA-associated vasculitis and ApoA1-VAP2 complex

Region

Japan


Condition

Condition

ANCA-associated vasculitis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the role of ApoA1-VAP2 complex in patients with ANCA-associated vasculitis

Basic objectives2

Others

Basic objectives -Others

To establish the measuring system of ApoA1-VAP2 complex by ELISA

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

serum ApoA1-VAP2 complex levels in active/inactive ANCA-associated vasculitis and healthy control

Key secondary outcomes



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

ANCA-associated vasculitis patients who fulfilled the definition of 2012 Chapel Hill Consensus Conference

Key exclusion criteria

1. Less than 20 years old
2. Eosinophilic granulomatosis with polyangiitis

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shunsuke
Middle name
Last name Furuta

Organization

Chiba University Hospital

Division name

Allergy and Clinical Immunology

Zip code

260-8670

Address

1-8-1 Inohana, Chuou-ku, Chiba

TEL

0432227171

Email

shfuruta@gmail.com


Public contact

Name of contact person

1st name Shunsuke
Middle name
Last name Furuta

Organization

Chiba University Hospital

Division name

Allergy and Clinical Immunology

Zip code

260-8670

Address

1-8-1 Inohana, Chuou-ku, Chiba

TEL

0432227171

Homepage URL


Email

shfuruta@gmail.com


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

institutional review board of Chiba University

Address

1-8-1 Inohana, Chuou-ku, Chiba

Tel

0432227171

Email

inohana-rinri@chiba-u.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 04 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

Terminated

Date of protocol fixation

2021 Year 01 Month 21 Day

Date of IRB

2021 Year 02 Month 22 Day

Anticipated trial start date

2021 Year 02 Month 22 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a study investigating the disease mechanism without any intervention. Serum ApoA1-VAP2 complex levels will be measured using blood samples from ANCA-associated vasculitis patients. ApoA1-VAP2 complex is known as an aggravating factor of the disease in the mice model.
Our IRB recommended us to register this study, though this study is not a clinical trial.


Management information

Registered date

2021 Year 03 Month 16 Day

Last modified on

2021 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name