NCT02649413

Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome, Minimal Change

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2016-01-07
• Last updated: 2016-01-12

Locations

1 site across 1 country: Israel