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Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glomerular Disease

Intervention: prednisone 60 mg/meter square Body Surface Area (Drug); prednisone 45 mg (Drug); prednisone 30 mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Amit Dagan, Doctor, Principal Investigator, Affiliation: nephrology institute Shneider Children Hospital
Amit Dagan, Doctor, Principal Investigator, Affiliation: Schneider childrens Hospital Nephrology Institute


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?

Clinical Details

Official title: Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Nephrotic Syndrome Remission

Secondary outcome: Remission duration

Detailed description: 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.


Minimum age: 1 Year. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- Patients with Idiopathic nephrotic syndrome with a flair that needs steroids

treatment. Exclusion Criteria:

- Steroid resistance or treatment with Cyclosporin or Cellcept

Locations and Contacts

Shneider children Hospital Nephrology Institute, Petach-Tikva, Israel; Not yet recruiting
Amit Dagan, Doctor, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: August 13, 2014

Page last updated: August 23, 2015

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