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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036873
Receipt No. R000042015
Scientific Title Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Date of disclosure of the study information 2019/06/01
Last modified on 2019/07/02

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Basic information
Public title Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Acronym Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Scientific Title Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Scientific Title:Acronym Analysis of clinical features and prognosis of anti-neutrophil cytoplasmic antibody-associated vasculitis
Region
Japan

Condition
Condition anti-neutrophil cytoplasmic antibody associated vasculitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 analysis of clinical features and prognosis
Basic objectives2 Others
Basic objectives -Others To study organ involvement associated with vasculitis, outcomes of relapses, occurrences of adverse events, discontinuing of immunosuppressants, and survival rate.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To study outcomes of relapses, occurrences of adverse events, discontinuing of immunosuppressants, and survival rate, for five years.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with vasculitis, whose ANCA is positive, attending Clinical Immunology and Rheumatology, Jichi Medical University Hospital.
Key exclusion criteria none
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Murosaki
Organization Jichi Medical University Hospital
Division name Clinical Immunology and Rheumatology
Zip code 3290498
Address 3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
TEL 0285587358
Email r0752tm@jichi.ac.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Murosaki
Organization Jichi Medical University Hospital
Division name Clinical Immunology and Rheumatology
Zip code 3290498
Address 3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
TEL 0285587358
Homepage URL
Email r0752tm@jichi.ac.jp

Sponsor
Institute Jichimedical University
Institute
Department

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 JIchi Medical University
Address 3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture
Tel 0285588933
Email nintei-rinri@jichi.ac.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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 28 Day
Last follow-up date
2024 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze the clinical informations including clinical features, for example relapse, organ involvement, adverse event, discontinuing of immunosuppressant, and survival rate, retrospectively, about patients with ANCA associated vasculitis attending our devision.

Management information
Registered date
2019 Year 05 Month 28 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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