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JAPANESE
国立保健医療科学院
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

Outcome(s)

Primary OutcomeComplete remission rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum1years-old
Age maximum18years-old
GenderMale and Female
Include criteria1.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.
Exclude criteria1.Congenital nephrotic syndrome. 2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Sch&ouml;nlein 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

Contact

public contact
Name
Address Japan
Telephone
E-mail
Affiliation Japanese Study Group of Kidney Disease in Children Tokyo Metropolitan Children&amp;#39;s Medical Center
scientific contact
Name Shuichi Ito
Address 2-10-1 Okura Setagaya-ku, Tokyo Japan
Telephone
E-mail
Affiliation National Center for Child Health and Development Department of Pediatric Nephrology and Rheumatology