Unique ID issued by UMIN | C000000010 |
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Receipt number | R000000015 |
Scientific Title | Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children |
Date of disclosure of the study information | 2005/08/01 |
Last modified on | 2010/11/12 10:06:40 |
Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children
Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children
Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children
Cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children
Japan |
Frequently relapsing nephrotic syndrome in children
Nephrology | Pediatrics |
Others
NO
We investigate efficacy and safety of cyclosporine C0 monitoring for frequently relapsing nephrotic syndrome in children.
Safety,Efficacy
Relapse-free rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Cyclosporine C0 monitoring
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 relapses or prednisolone dependence, 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 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.
60
1st name | |
Middle name | |
Last name | Masahiro Ikeda |
Tokyo Metropolitan Children's Hospital
Department of Nephrology
1-3-1Umezono Kiyose City,Tokyo
1st name | |
Middle name | |
Last name |
Japanese Study Group of Renal Disease in Children
Department of Nephrology,Tokyo Metropolitan Children's Hospital
Japanese Study Group of Renal Disease in Children
The Kidney Foundation,Japan
Non profit foundation
NO
2005 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2000 | Year | 01 | Month | 01 | Day |
2000 | Year | 01 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2005 | Year | 06 | Month | 14 | Day |
2010 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000015
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