Unique ID issued by UMIN | UMIN000000747 |
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Receipt number | R000000902 |
Scientific Title | Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial |
Date of disclosure of the study information | 2007/09/01 |
Last modified on | 2015/04/14 09:51:22 |
Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial
Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children(JSKDC04)
Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial
Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children(JSKDC04)
Japan |
Idiopatic nephrotic syndrome in children
Nephrology | Pediatrics |
Others
NO
To demonstrate the non-inferiority of time to frequent relapse of taclorimus compared with cyclosporine for children with frequently relapsing nephrotic syndrome
Safety,Efficacy
Confirmatory
Time to frequent relapse
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
PSL for 2 months
PSL for 6 months
1 | years-old | <= |
15 | years-old | >= |
Male and Female
1)The first episode of idiopathic nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL).
2)Treated with predonisolone 60 mg/m2/day single daily dosing for 4 weeks.
3)Diagnosis of steroid sensitive NS has been performed within within the third week after the onset of PSL therapy.
4)Aged twelve months to 15 years.
5)Written informed consent from the patients' parents or legal guardians.
1)Other renal nephrotic syndrome(IgA nephropathy)
2)Henoch-Schönlein nephritis, systemic lupus erythematosus
3)History of immunosuppressant administration.
4)Poorly controlled hypertension.
5)Renal dysfunction(creatinine clearance < 60 mL/min).
6)Active infectious disease.
7)Severe liver disfunction.
8)Pregnancy.
9)Judged inappropriate for this study by the physicians.
250
1st name | |
Middle name | |
Last name | Norishige Yoshikawa |
Wakayama Medical University
Department of Pediatrics
811-1 Kimiidera Wakayama City Wakayama
073-441-0633
nori@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Nakanishi |
Japanese Study Group of Kidney Disease in Children
Department of Pediatrics, Wakayama Medical University
073-441-0633
jskdc@wakayama-med.ac.jp
Japanese Study Group of Kidney Disease in Children
Ministry of Health, Labour and Welfare
NO
2007 | Year | 09 | Month | 01 | Day |
Published
Completed
2007 | Year | 06 | Month | 18 | Day |
2007 | Year | 09 | Month | 01 | Day |
2013 | Year | 01 | Month | 31 | Day |
2007 | Year | 06 | Month | 25 | Day |
2015 | Year | 04 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000902
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