Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well. Response to this treatment is the most important prognostic factor and this patients has a benign disease course. 60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration. guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion. Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?
Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will response to this treatment. The course of the disease is characterized of recurrent relapses and repeated prednisone therapy. While prednisone doses and therapy duration in the disease diagnosis has been based on multiple prospective studies, the dose and therapy duration in the relapses was never challenged in a prospective control study. To address this question we designed prospective 3 arm study to evaluate the effective of exception steroid regiment to treat relapses versus lower doses. The study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome. After relapse will be diagnosed based on physical exam and urine tests, the patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2. A measurement of time to obtain remission, duration of remission est. will be collected. We plan to recruit 100 children in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
treatment with 45 mg prednisone to compare with other arms
treatment with 30 mg prednisone to compare with other arms.
Shneider children Hospital Nephrology Institute
Petah Tikva, Israel
Nephrotic Syndrome Remission
Undetectable protein in urine for 3 days
Time frame: 3 days
Remission duration
The number of weeks since the patient stopped steroids therapy and was in a complete remission.
Time frame: Weeks
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