Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Idiopathic Nephrotic Syndrome.
Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
Summary
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for
nephrotic syndrome.This Randomized Clinical Trial seeks to evaluate whether Rituximab
biosimilar maintains drug-free disease remission in patients with steroid-dependent nephrotic
syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil (1,200 mg/m2
orally in 2 daily doses). The investigators will compare the risk of relapse to test this
hypothesis (primary outcome). Secondary objectives will include assessing short- and
long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients
will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where
laboratory studies will be performed at in-site facilities.