NIPH Clinical Trials Search

UMIN ID: C000000009

Registered date:01/08/2005

Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSteroid-resistant nephrotic syndrome in children
Date of first enrollment2001/04/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cyclosporine+prednisolone Methylprednisolone+cyclosporine+prednisolone


Primary OutcomeComplete remission rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum1years-old
Age maximum18years-old
GenderMale and Female
Include criteria
Exclude criteria1.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.

Related Information


public contact
Address Japan
Affiliation Japanese Study Group of Renal Disease in Children Department of Nephrology, Tokyo Metropolitan Children's Hospital
scientific contact
Name Masataka Honda
Address 4-33-13 Daimachi Hachioji City,Tokyo Japan
Affiliation Tokyo Metropolitan Children's Hospital Department of Pediatrics