Open-label, randomized, controlled trial due to value whether the monoclonal antibody
rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS.
We will enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been
in treatment with steroids for at least one year. The lowest dose of drug required to
maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day.
This trial provides an initial run-in phase of one month during wich remission will be
achieved by means of a standard oral prednisone course. Once remission has been achieved
children will be randomized in a parallel arm open label RCT to continue prednisone alone for
one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 -
intervention). Prednisone will be tapered in both arms after one month.