Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

Nephrotic Syndrome, Minimal Change Clinical Trial

— AJSNS  

Official title:

Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02649413
• Other study ID #: 695 RMC -AJSNS
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 31, 2015
• Last updated: January 11, 2016
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: December 2015
• Source: Rabin Medical Center
• Contact: Amit Dagan, Dr.
• Phone: 9723-9253979
• Email: DaganA[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Nephrotic Syndrome, Minimal Change
• Syndrome

Intervention

Drug:
• Prednisone
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.

Locations

Country	Name	City	State
Israel	Shneider children Hospital Nephrology Institute	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of relapse during first year	We will count the number of relapse episodes in the first year since diagnosis.	one year	Yes