Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome
- Conditions
- Steroid-Dependent Nephrotic Syndrome
- Interventions
- Drug: immunoglobulin IV
- Registration Number
- NCT03560011
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- Detailed Description
Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 90
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab followed by 5 injections of immunoglobulin IV immunoglobulin IV Rituximab (375 mg/m²) followed by 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). Treatment duration : 6 months
- Primary Outcome Measures
Name Time Method The occurrence of the first relapse 24 months Relapse is defined as a protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher
- Secondary Outcome Measures
Name Time Method Time to first relapse 24 months Cumulative amount of corticosteroid over a 24 months follow-up 24 months Adverse events in each arm 24 months Number of relapse over a 24 months follow-up 24 months
Trial Locations
- Locations (1)
Robert Debre Hospital
🇫🇷Paris, France
Robert Debre Hospital🇫🇷Paris, France