Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

Phase 4

• Conditions: Nephrotic Syndrome, Minimal Change
• Interventions: Drug: Prednisone

• Registration Number: NCT02649413
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-31
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12
• Study Start: 2016-03
• Primary Completion: 2019-04
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Children who recently have been diagnosed with nephrotic syndrome.

Exclusion Criteria

• Children with nephrotic syndrome that can not be treated with steroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early response to prednisone treatment	Prednisone	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.

Primary Outcome Measures

Name	Time	Method
The time until the first relapse	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.

Secondary Outcome Measures

Name	Time	Method
Number of relapse during first year	one year	We will count the number of relapse episodes in the first year since diagnosis.

Trial Locations

Locations (1)

Shneider children Hospital Nephrology Institute; 🇮🇱 Petach-Tikva, Israel