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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005136
Receipt No. R000006001
Scientific Title Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis and rapidly progressive glomerulonephritis
Date of disclosure of the study information 2011/03/31
Last modified on 2017/03/01

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Basic information
Public title Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis and rapidly progressive glomerulonephritis
Acronym New RemiT-JAV-RPGN
Scientific Title Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis and rapidly progressive glomerulonephritis
Scientific Title:Acronym New RemiT-JAV-RPGN
Region
Japan

Condition
Condition ANCA-associated vasculitis and rapidly progressive glomerulonephritis
Classification by specialty
Medicine in general Nephrology Clinical immunology
Dermatology Oto-rhino-laryngology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know the efficacy and safety of remission induction therapy for ANCA-associated vasculitis and RPGN in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time to remission
Key secondary outcomes Survival
Cause of death
Treatment response
Relapse
Severe infections and risk factor
Other adverse events
Pathologic analysis in pulmonary limited vasculitis
Pathologic analysis in renal limited vasculitis
Pathological analysis of renal involvement
Radiological analysis of pulmonary involvement
Intraclass correlation coefficients of the criteria
Identification of candidate biomarker

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 Patients with newly diagnosed ANCA related vasculitis
No previous treatments
Key exclusion criteria Patients with relapse
Malignancy
Replicating hepatitis B and C
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Makino
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL 086-235-7235
Email vas-mhlw@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ei Sada
Organization Research Committe of Intractable Vasculitis Syndrome of the MHLW of Japan
Division name Secretariat
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL 086-235-7235
Homepage URL
Email vas-mhlw@md.okayama-u.ac.jp

Sponsor
Institute Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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 岡山大学(岡山県)、杏林大学(東京都)、香川大学(香川県)、東京医科歯科大学(東京都)、順天堂大学(東京都)、埼玉医科大学(埼玉県)、筑波大学(茨城県)、新潟県立リウマチセンター(新潟県)、聖マリアンナ医科大学(神奈川県)、京都大学(京都府)、宮崎大学(宮崎県)、愛知医科大学(愛知県)、名古屋市立大学(愛知県)、東邦大学(東京都)、東京大学(東京都)、愛媛大学(愛媛県)、島根大学(島根県)、浜松医科大学(静岡県)、東京医科大学八王子医療センター(東京都)、新潟大学(新潟県)、長崎大学(長崎県)、北海道大学(北海道)秋田大学(秋田県)、岩手県立中央病院(岩手県)、岡山済生会総合病院(岡山県)、名古屋大学(愛知県)、東京慈恵会医科大学第三病院(東京都)、東京慈恵会医科大学柏病院(千葉県)、福島県立医科大学(福島県)、藤田保健衛生大学(愛知県)、田附興風会医学研究所北野病院(京都府)、東京女子医科大学(東京都)、金沢大学(石川県)、仙台社会保険病院(宮城県)、東京医科大学茨城医療センター(茨城県)、福岡大学(福岡県)、横浜市立大学(神奈川県)、自治医科大学(栃木県)、自治医科大学附属埼玉医療センター(埼玉県)、名古屋第二赤十字病院(愛知県)、福岡県済生会八幡総合病院(福岡県)、福岡東医療センター(福岡県)、旭川医科大学(北海道)、九州大学(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.tandfonline.com/doi/abs/10.3109/14397595.2016.1140274
Number of participants that the trial has enrolled
Results The RPGN grading system was more useful to predict 6-month overall and ESRD-free survival than the EUVAS-defined severity or FFS 2009.
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 Main results already published
Date of protocol fixation
2011 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 01 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2017 Year 03 Month 01 Day

Other
Other related information The efficacy and safety of concomitant immunosuppressant usage are evaluated

Management information
Registered date
2011 Year 02 Month 25 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006001

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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