Efficacy and Safety of mizoribine for MPO-ANCA associated vasculitis; A multicenter randomized controlled trial (Mizoribin for ANCA RPGN Relapse-Prevention study:MARPGN study)

UMIN ID: UMIN000000708

Registered date:06/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: MPO-ANCA associated vasculitis
• Date of first enrollment: 2007/03/01
• Target sample size: 126
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

treatment with mizoribine according to the GFR once a day
no treatment with mizoribine

Outcome(s)

• Primary Outcome: BVAS score, time from remmision to relapse, relapse rate
• Secondary Outcome: MPO-ANCA titer, CRP, GFR, amount dose of corticosteroid through the study

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients with allergy with Mizoribine Patients with leucocytosis(<3000/mm3) Patients treated with other immunosuppression drug within four weeks

Related Information

• Primary Sponsor: Department of Nephrology, Division of Clinical Sciences, Faculty of Medicine, University of Tsukuba
• Secondary Sponsor: none
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Asahi Kasei Pharma Corporation