Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial

UMIN ID: C000000008

Registered date:01/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Frequently relapsing nephrotic syndrome in children
• Date of first enrollment: 2005/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Cyclosporine C2 monitoring with higher target levels
Cyclosporine C2 monitoring by lower target levels

Outcome(s)

• Primary Outcome: Relapse-free rate

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: 1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.History of steroid resistance. 3.Medical history of allergy or hypersensitivity reactions to cyclosporine. 4.Poorly controlled hypertension. 5.Chronic renal dysfunction. 6.Active infectious disease. 7.Severe liver disfunction. 8.History of cyclosporine administration. 9.Pregnancy. 10.Judged inappropriate for this study by the physicians.

Related Information

• Primary Sponsor: Japanese Study Group of Kidney Disease in Children
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare