Glomerular Disease Clinical Trial
Official title:
Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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