NIPH Clinical Trials Search

UMIN ID: C000000007

Registered date:01/08/2005

A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children: A randomized controlled study

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedSteroid-resistant nephrotic syndrome in children
Date of first enrollment2005/04/01
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cyclosporine+prednisolone treatment for 2 years Methylprednisolone+cyclosporine+prednisolone treatment for 2 years


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 Kidney Disease in Children Tokyo Metropolitan Children's Medical Center
scientific contact
Name Shuichi Ito
Address 2-10-1 Okura Setagaya-ku, Tokyo Japan
Affiliation National Center for Child Health and Development Department of Pediatric Nephrology and Rheumatology