Overview

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