Unique ID issued by UMIN | C000000379 |
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Receipt number | R000000469 |
Scientific Title | Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) |
Date of disclosure of the study information | 2006/04/01 |
Last modified on | 2008/10/30 13:31:12 |
Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)
Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)
Japan |
Steroid-sensitive nephrotic syndrome
Nephrology | Pediatrics |
Others
NO
By comparing prednisolone only and a combination of prednisolone and mizoribine, the better is selected as a standard treatment for for primary nephrotic syndrome relapsed within six mounths after first onset in children in our group.
Safety,Efficacy
Relapse-free period
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
prednisolone
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.First replase happended within 6 mounths after first onset.
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.History of saireito and immunosupression administration.
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 Nephrology,Tokyo Metropolitan Children's Hospital
Japanese Study Group of Renal Disease in Children(JSRDC)
The Kidney Foundation,Japan
Non profit foundation
NO
2006 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2001 | Year | 03 | Month | 10 | Day |
2001 | Year | 04 | Month | 01 | Day |
2005 | Year | 03 | Month | 01 | Day |
2005 | Year | 06 | Month | 01 | Day |
2005 | Year | 06 | Month | 01 | Day |
2005 | Year | 07 | Month | 01 | Day |
2006 | Year | 03 | Month | 29 | Day |
2008 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000469
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