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Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
2 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2019-04-03
Completion Date
2022-11-04
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
immunoglobulin IV
5 injections of immunoglobulin IV once a month during 5 months (2g/kg at M1, 1.5g/kg at M2 to M5, maximal dose 100g)
Locations (1)
Robert Debre Hospital
Paris, France