Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome (AJSNS)

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Nephrotic Syndrome, Minimal Change

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02649413

695 RMC -AJSNS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children who recently have been diagnosed with nephrotic syndrome.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Early response to prednisone treatment

Experimental group

Description:

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.

Treatment:

Drug: Prednisone