NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000005136

Registered date:31/03/2011

Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis and rapidly progressive glomerulonephritis

Basic Information

Public titleObservational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis and rapidly progressive glomerulonephritis
Scientific title
Recruitment statusComplete: follow-up complete
Health condition(s) or Problem(s) studiedANCA-associated vasculitis and rapidly progressive glomerulonephritis
Study typeObservational
Phase
Study design
Intervention(s)
Sample Size250
Date of first enrollment2011/04/01
Completion dateNone
Countries of recruitmentJapan

Outcome(s)

Primary OutcomeTime to remission
Secondary OutcomeSurvival 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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteriaPatients with newly diagnosed ANCA related vasculitis No previous treatments
Exclude criteriaPatients with relapse Malignancy Replicating hepatitis B and C

Related Information

Primary SponsorResearch Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
Secondary
Source(s)The Ministry of Health, Labor and Welfare of Japan

Secondary Identifiers

Secondary ID

Contact

public contact
Name Ken-ei Sada
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan Japan
Telephone 086-235-7235
E-mail vas-mhlw@md.okayama-u.ac.jp
Affiliation Research Committe of Intractable Vasculitis Syndrome of the MHLW of Japan Secretariat
scientific contact
Name Hirofumi Makino
Address 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan Japan
Telephone 086-235-7235
E-mail vas-mhlw@md.okayama-u.ac.jp
Affiliation Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Ethics Reviews

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Summary Results

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Baseline Characteristics
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IPD sharing statement

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