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
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
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
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
