Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose

Conditions
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Glomerular Disease

Intervention / Treatment
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* Drug: prednisone 60 mg/meter square Body Surface Area
* Drug: prednisone 45 mg
* Drug: prednisone 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment. Exclusion Criteria: Steroid resistance or treatment with Cyclosporin or Cellcept

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prednisone 60 mg/meter square Body Surface Aera<br>A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end. | Drug: prednisone 60 mg/meter square Body Surface Area<br>* treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms<br>* Other names: Danalon;|
| Active Comparator: prednisone 45 mg/meter square BSA<br>B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended. | Drug: prednisone 45 mg<br>* treatment with 45 mg prednisone to compare with other arms<br>* Other names: Danalon;|
| Active Comparator: prednisone 30 mg/meter squer BSA<br>C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended. | Drug: prednisone 30 mg<br>* treatment with 30 mg prednisone to compare with other arms.<br>* Other names: Danalon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nephrotic Syndrome Remission | Undetectable protein in urine for 3 days | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission duration | The number of weeks since the patient stopped steroids therapy and was in a complete remission. | Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Nephrotic syndrome relapse