Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

NCT ID: NCT02649413

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-06-30

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.

Conditions

Nephrotic Syndrome, Minimal Change

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early response to prednisone treatment

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.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

corticosteroids

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Dagan, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shneider children Hospital Nephrology Institute

Locations

Shneider children Hospital Nephrology Institute

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Amit Dagan, Dr.

Role: CONTACT

DaganA@clalit.org.il

9723-9253979

Amit Dagan, Dr.

Role: CONTACT

DaganA@clalit.org.il

972-925379

Other Identifiers

695 RMC -AJSNS

Identifier Type: -

Identifier Source: org_study_id