Unique ID issued by UMIN | C000000008 |
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Receipt number | R000000011 |
Scientific Title | Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial |
Date of disclosure of the study information | 2005/08/01 |
Last modified on | 2016/08/19 09:39:11 |
Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)
Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)
Japan |
Frequently relapsing nephrotic syndrome in children
Nephrology | Pediatrics |
Others
NO
By comparing two target cyclosporine C2 levels,the better is selected as a standard treatment for frequently relapsing nephrotic syndrome in children in our group.
Safety,Efficacy
Relapse-free rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Cyclosporine C2 monitoring with higher target levels
Cyclosporine C2 monitoring by lower target levels
1 | years-old | <= |
18 | years-old | >= |
Male and Female
1.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.
1.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.
100
1st name | |
Middle name | |
Last name | Kazumoto Iijima |
Division of Child Health and Development
Kobe University Graduate School of medicine
Department of Pediatrics
5-1 Kusunoki-cho 7 chome Kobe City
078-382-6093
iijima@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Nakanishi |
Japanese Study Group of Kidney Disease in Children
Department of Pediatrics, Wakayama Medical University
811-1 KImiidera Wakayama City
073-441-0633
jskdc@wakayama-med.ac.jp
Japanese Study Group of Kidney Disease in Children
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
2005 | Year | 08 | Month | 01 | Day |
Published
Completed
2005 | Year | 04 | Month | 25 | Day |
2005 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2005 | Year | 06 | Month | 14 | Day |
2016 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000011
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