drugset / Trial / NCT02216747

Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

NCT02216747 ↗

Phase 4 Unknown 100 enrolled Rabin Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

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?

Timeline

Start
2014-09
Primary completion
2015-10
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisone Other / unclassified 30 mg/m2 —
Comparator Prednisone Other / unclassified 45 mg/m2 —
Comparator Prednisone Other / unclassified 60 mg/m2 —

Indications