Clinical trial NCT02216747: Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse
Official title: Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glomerular Disease
Keywords: Idiopathic Nephrotic syndrome relapse
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?

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.

Eligibility criteria: Inclusion Criteria:

* Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.

Exclusion Criteria:

* Steroid resistance or treatment with Cyclosporin or Cellcept

Primary outcomes:
measure: Nephrotic Syndrome Remission
timeFrame: 3 days
Secondary outcomes:
measure: Remission duration
timeFrame: Weeks
Other outcomes:
measure: Edema
timeFrame: within 14 days
Locations:
city: Petach-Tikva
country: Israel
facility: Shneider children Hospital Nephrology Institute
Study officials:
affiliation: nephrology institute Shneider Children Hospital
name: Amit Dagan, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Schneider childrens Hospital Nephrology Institute
name: Amit Dagan, Doctor
role: PRINCIPAL_INVESTIGATOR
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