Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome
AJSNS
Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJanuary 12, 2016
December 1, 2015
3.1 years
December 31, 2015
January 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Number of relapse during first year
one year
Study Arms (1)
Early response to prednisone treatment
EXPERIMENTALintervention -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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children who recently have been diagnosed with nephrotic syndrome.
You may not qualify if:
- Children with nephrotic syndrome that can not be treated with steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shneider children Hospital Nephrology Institute
Petah Tikva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Dagan, Dr.
Shneider children Hospital Nephrology Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2015
First Posted
January 7, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2019
Study Completion
June 1, 2019
Last Updated
January 12, 2016
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share