NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000008

Registered date:01/08/2005

Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedFrequently relapsing nephrotic syndrome in children
Date of first enrollment2005/04/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cyclosporine C2 monitoring with higher target levels Cyclosporine C2 monitoring by lower target levels

Outcome(s)

Primary OutcomeRelapse-free 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.Frequently relapse or steroid independence, 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 12 months before eligibility. 4.Aged twelve months to 18 years. 5.Written informed consent from the patients' parents or legal guardians.
Exclude criteria1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.History of steroid resistance. 3.Medical history of allergy or hypersensitivity reactions to 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 Nakanishi
Address 811-1 KImiidera Wakayama City Japan
Telephone 073-441-0633
E-mail jskdc@wakayama-med.ac.jp
Affiliation Japanese Study Group of Kidney Disease in Children Department of Pediatrics, Wakayama Medical University
scientific contact
Name Kazumoto Iijima
Address 5-1 Kusunoki-cho 7 chome Kobe City Japan
Telephone 078-382-6093
E-mail iijima@med.kobe-u.ac.jp
Affiliation Division of Child Health and Development Kobe University Graduate School of medicine Department of Pediatrics