B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).
Age between 3 and 18 years
2 or more relapses during steroids or within 2 weeks following discontinuation.
2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal
2 or more relapses within 6 months following first remission
Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
Primary or secondary steroid resistance nephrotic syndrome
Prior treatment with Rituximab within 6 months
Prior treatment with obinutuzumab at any time
Parallel
single infusion of Rituximab
Drugsingle infusion of Rituximab 375 mg/m2
single infusion of Obinutuzumab
Drugsingle infusion of Obinutuzumab 300mg/1.73 m2
Occurrence of a relapse within 12 months following the initiation of treatment
Relapse is defined as a protein to creatinine ratio of 2 g/g of creatinine (0.20 g/mmol) or higher
Occurrence of a relapse within 24 months
Time to B-cell depletion
Duration of relapse-free survival after B-cell reconstitution
Cumulative steroid courses and second line immunosuppressive treatments in patients with relape
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