Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

• Status: Suspended
• Trial end date: 2022-11-04
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Rituximab

Criteria

Inclusion Criteria:

• Childhood onset nephrotic syndrome (first flair <18 years)

• ≥ 2 years old at inclusion

• Steroid-dependent:

• Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.

• Patient with at least 2 relapses including one under steroidsparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, Levamisole) or within 6 months of treatment withdrawal.

• or with frequent relapses:

· 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.

• with a relapse within 3 months prior to inclusion

• In remission: Protein-over-creatinine ratio ≤ 0.2g/g (≤ 0.02g/mmol)

Exclusion Criteria:

• Patients with steroid-resistant nephrotic syndrome;

• Patients with genetic nephrotic syndrome;

• Patients previously treated with rituximab;

• Patients with no affiliation to a social security scheme (beneficiary or legal);

• Prior Hepatitis B, Hepatitis C or HIV infection;

• Pregnancy or breastfeeding.

• Patients with hyperprolinaemia,

• Known hypersensitivity to one of the study medication,

• Scheduled and not postponable injection of live attenuated vaccine

• Protected adults

• Patients with neutrophils < 1.5 G/L and/or platelets < 75 G/L