Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome (AJSNS)
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|ClinicalTrials.gov Identifier: NCT02649413|
Recruitment Status : Unknown
Verified December 2015 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : January 7, 2016
Last Update Posted : January 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Nephrotic Syndrome, Minimal Change||Drug: Prednisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Early response to prednisone treatment
intervention -children that will have a remission in 8 days (response) will get an adjusted steroids dose treatment.children that have a remission between 9-28 days will get a regular steroid dose.
Children with Idiopathic Nephrotic syndrome will start 60 mg/m2 prednisone.children that response in 8 days will receive an adjusted dose while the rest of the group will receive the 4 weeks usually dose.
Other Name: corticosteroids
- The time until the first relapse [ Time Frame: 6 months ]All Children with Nephrotic Syndrome will start a dose of 60 mg/m2 prednisone.patients that will response in 8 days (the first day with a negative or trace in the urine deep stick test)will receive adjusted lower steroid dose.the outcome is the time until the first relapse( positive protein in deep stick urine test,or low serum albumin with positive urine deep stick).the control group is the historical data from a prospective malty center observation study.
- Number of relapse during first year [ Time Frame: one year ]We will count the number of relapse episodes in the first year since diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649413
|Contact: Amit Dagan, Dr.||9723-9253979||DaganA@clalit.org.il|
|Contact: Amit Dagan, Dr.||972-925379||DaganA@clalit.org.il|
|Shneider children Hospital Nephrology Institute|
|Principal Investigator:||Amit Dagan, Dr.||Shneider children Hospital Nephrology Institute|