A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
- Conditions
- Frequently relapsing nephrotic syndrome in children
- Registration Number
- JPRN-UMIN000004204
- Lead Sponsor
- Japanese Study Group of Kidney Disease in Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Not provided
(1)Other renal nephrotic syndrome (IgA nephropathy) (2)History of Henoch-Schounlein nephritis, systemic lupus erythematosus or secondary nephrotic syndrome (3)History of steroid resistant NS (4)Prior treatment of cyclosporine or tacrolimus (5)History of immunosuppressants administration against nephrotic syndrome within one month before eligibility (6)History of allergy or hypersensitivity reactions to cyclosporine or tacrolimus (7)Either father or mother has diagnosed with diabetes mellitus (8)Fasting blood glucose level more than 110 mg/dL/casual blood glucose level more than 200 mg/dL or HbA1c(NSGP) more than 6.4%, History of diabetes mellitus that needs medical attention administration (9)Body Mass Index more than 30 (10)Uncontrollable hypertension (11)Renal dysfunction (creatinine clearance < 60 mL/min) (12)Severe liver dysfunction (13)Active infectious disease (14)Women during pregnancy or who wish pregnancy during therapy (15)Patients enrolling another clinical trials (16)Judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free time
- Secondary Outcome Measures
Name Time Method