Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Levamisole

Criteria

Inclusion Criteria:

• Age 24 months < age < 16 years

• Diagnosis of first manifestation of INS defined by:

• hypoalbuminemia < 25g/l, proteinuria > 0.20 g/mmol of urinary creatinine

• normal C3 fraction of complement

• Use of mechanical contraception for patients of reproductive age throughout the research period

• Beneficiary of a social protection scheme (except AME)

• Written informed consent from one of both parents

• Ability to realise follow-up in full

Exclusion Criteria:

• Anteriority of INS

• Pregnancy, breast feeding or planned pregnancy during the study

• Malignant pathology (antecedent or ongoing), diabetes, liver disease

• Hypersensitivity to levamisole or its excipients (lactose)