Unique ID issued by UMIN | C000000158 |
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Receipt number | R000000016 |
Scientific Title | Mizoribin for primary nephrotic syndrome in children(JSRDC09) |
Date of disclosure of the study information | 2006/04/01 |
Last modified on | 2008/12/09 09:52:11 |
Mizoribin for primary nephrotic syndrome in children(JSRDC09)
Mizoribin for primary nephrotic syndrome in children(JSRDC09)
Mizoribin for primary nephrotic syndrome in children(JSRDC09)
Mizoribin for primary nephrotic syndrome in children(JSRDC09)
Japan |
Steroid-sensitive nephrotic syndrome
Nephrology | Pediatrics |
Others
NO
We investigate efficacy and safety of a combination of mizoribine and prednisolone for steroid-sensitive nephrotic syndrome in children, comparing with prednisolone.
Safety,Efficacy
Relapse-free proportion
Relapse-free time
Freaquently relapse rate
Steroid dependency rate
Relapse rate
Proportion f adverse events
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Historical
1
Treatment
Medicine |
mizoribine+prednisolone
1 | years-old | <= |
10 | 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.Patients with treatment either based on the International study of kidney disease in children (ISKDC) or similar to ISKDC.
3.Steroid-sensitive nephrotic syndrome in first onset.
4.Biopsy diagnoses of MCNS, where a renal biopsy has been performed before eligibility, in the patients with hematuria.
5.Aged twelve months to 18 years.
6.Written informed consent from the patients' parents or legal guardians.
1.History of relapse.
2.Medical history of allergy or hypersensitivity reactions to mizoribine.
3.Poorly controlled hypertension.
4.Chronic renal dysfunction.
5.Active infectious disease.
6.Severe liver disfunction.
7.Hypocomplementemia
8.Pregnancy.
9.Judged inappropriate for this study by the physicians.
50
1st name | |
Middle name | |
Last name | Norishige Yosikawa |
Wakayama Medical University
Department of Pediatrics
811-1 Kimiidera Wakayama City Wakayama
1st name | |
Middle name | |
Last name |
Japanese Study Group of Renal Disease in Children(JSRDC)
Department of Pediatrics,Wakayama Medical University
Japanese Study Group of Renal Disease in Children(JSRDC)
The Kidney Foundation,Japan
Non profit foundation
NO
2006 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2005 | Year | 09 | Month | 11 | Day |
2008 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000016
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