Steroid-resistant nephrotic syndrome in children
Conditions
Interventions
Cyclosporine+prednisolone treatment for 2 years
Methylprednisolone+cyclosporine+prednisolone treatment for 2 years
Sponsors
Japanese Study Group of Kidney Disease in Children
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL). 2.Corticosteroid resistance after 4 weeks of daily prednisolone, or serum albumin level <2.5 g/dL after 4 subsequent weeks of alternate-day therapy, in cases of partial remission despite 4 weeks of daily prednisolone, based on the International study of kidney disease in children. 3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 8 weeks before eligibility. 4.Aged twelve months to 18 years. 5.Written informed consent from the patients' parents or legal guardians.
Exclusion criteria
Exclusion criteria: 1.Congenital nephrotic syndrome. 2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 3.Medical history of allergy or hypersensitivity reactions to methylprednisolone and 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate | — |
Countries
Japan
Contacts
Public ContactKenji Ishikura
Japanese Study Group of Kidney Disease in Children Tokyo Metropolitan Children's Medical Center
Outcome results
None listed