Prospective study of the severity-based treatment protocol for Japanese patients with MPO-ANCA-associated vasculitis

UMIN ID: UMIN000000867

Registered date:30/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: MPO-ANCA-associated vasculitis
• Date of first enrollment: 2004/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): IVCY0.5-0.75g/m2 or oral CY 0.5-2.0mg/kg/day plus prednisolone 0.6-1.0mg/kg/day for the severe cases. Add plasma exchange for the most severe cases. Omit cyclophosphamide for aged cases with RPGN and dialysed cases. Prednisolone 0.5mg/kg alone or in conbination with azathioprine for the mild cases.

Outcome(s)

• Primary Outcome: remission induction, permanent renal failure and death
• Secondary Outcome: BVAS, VDI, SF-36, adverse effects

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. age over 80 2. active infection 3. WBC<4000 4. Platelt < 120,000 5. chronic dialysis 6. severe respiratory failure 7. liver cirrhosis 8. malignancy within 5 years 9. pregnancy 10. previous cumulative cyclophosphamide dosage > 10g

Related Information

• Primary Sponsor: Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
• Secondary Sponsor: Research Committe of Progressive Glomerular Disease of the Ministry of Health, Labor and Welfare of Japan
• Source(s) of Monetary Support: the Ministry of Health, Labor and Welfare of Japan