UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005136 |
|---|---|
| Receipt number | 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 17:26:09 |
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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
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
vas-mhlw@md.okayama-u.ac.jp
Sponsor or person
Institute
Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006001
