Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome (AJSNS)
Primary Purpose
Nephrotic Syndrome, Minimal Change
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome, Minimal Change
Eligibility Criteria
Inclusion Criteria:
- Children who recently have been diagnosed with nephrotic syndrome.
Exclusion Criteria:
- Children with nephrotic syndrome that can not be treated with steroids.
Sites / Locations
- Shneider children Hospital Nephrology Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early response to prednisone treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
The time until the first relapse
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.
Secondary Outcome Measures
Number of relapse during first year
We will count the number of relapse episodes in the first year since diagnosis.
Full Information
NCT ID
NCT02649413
First Posted
December 31, 2015
Last Updated
January 11, 2016
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02649413
Brief Title
Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome
Acronym
AJSNS
Official Title
Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the investigators will adjusted the first steroids does to the response day. Our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.
Detailed Description
About 90% of the patients will response to steroid therapy. The initial steroid dose is between 2mg/kg or 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The bases of this treatment have been put in the early 70s. Since then most of the study were focused on the duration of the therapy with a results that 8-12 weeks course is as good as 6 month. Studies have showed no difference in response rate between 2mg/kg to 60m2' although the difference in the dose in young children can rich to 25%. Other retrospective analysis been show that patients who response in the first 7-9 days tend to have lass relapses than other patients. In our nephrology clinic the investigators there is ongoing clinical study on low doses of steroid therapy for relapse of nephritic syndrome with good results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome, Minimal Change
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early response to prednisone treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
corticosteroids
Intervention Description
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.
Primary Outcome Measure Information:
Title
The time until the first relapse
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of relapse during first year
Description
We will count the number of relapse episodes in the first year since diagnosis.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children who recently have been diagnosed with nephrotic syndrome.
Exclusion Criteria:
Children with nephrotic syndrome that can not be treated with steroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Dagan, Dr.
Phone
9723-9253979
Email
DaganA@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Dagan, Dr.
Phone
972-925379
Email
DaganA@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Dagan, Dr.
Organizational Affiliation
Shneider children Hospital Nephrology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shneider children Hospital Nephrology Institute
City
Petach-Tikva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome
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