Glomerular Disease
Conditions
Keywords
Idiopathic Nephrotic syndrome relapse
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.
Interventions
DRUGprednisone 60 mg/meter square Body Surface Area
treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
DRUGprednisone 45 mg
treatment with 45 mg prednisone to compare with other arms
DRUGprednisone 30 mg
treatment with 30 mg prednisone to compare with other arms.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.
Exclusion criteria
* Steroid resistance or treatment with Cyclosporin or Cellcept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nephrotic Syndrome Remission | 3 days | Undetectable protein in urine for 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission duration | Weeks | The number of weeks since the patient stopped steroids therapy and was in a complete remission. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Edema | within 14 days | A sign of treatment resistance or no response. |
Countries
Israel
Outcome results
None listed