Randomized controlled trial of mizoribine for progressive IgA nephropathy

UMIN ID: UMIN000000593

Registered date:05/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: IgA nephropathy with moderate to severe histological alterations
• Date of first enrollment: 2006/11/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Methylprednisolone pulse therapy followed by oral prednisolone administration
Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration

Outcome(s)

• Primary Outcome: Altered amounts of proteinuria
• Secondary Outcome: Alteration of serum creatinine (SCr) and the slope of reciprocal SCr

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who have been treated with corticosteroids or mizoribine already 2) Patients who suffered infectious diseases such as pneumonia 3) Patients whose white blood cells count is under 3,000/mm3 4) Patients who are demonstrated to have another renal disease on renal biopsy 5) Patients who have diabetes mellitus 6) Patients who are have severe heart or liver disease 7) Patients who have malignant tumors 8) Patients who are currently pregnant or are supposed to be pregnant 9) Patients who are judged to be inappropriate for participation in this study by an physician

Related Information

• Primary Sponsor: West Japan Study Group for Therapy of IgA Nephropathy
• Source(s) of Monetary Support: The Kidney Foundation, Japan