This study focuses on children and young adults (2-25 years old) who have frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS), a condition that causes swelling in the body (especially in the face, legs, and feet) and changes in urine. The study will evaluate a drug called obinutuzumab compared to another drug called mycophenolate mofetil (MMF) in these patients. Fewer than half of patients on standard treatments for FRNS or SDNS have remission (where symptoms stop), and current treatment options often require taking a large amount of steroids. This study is looking for an alternative treatment that is effective and does not require frequent usage of steroids. Researchers will compare the effects of obinutuzumab versus MMF; participants will be randomly assigned to receive treatment with either obinutuzumab or MMF. In addition, they may receive their usual background tablets of corticosteroid (prednisone or a similar drug). Obinutuzumab is approved by the U.S. Food and Drug Administration for certain types of cancers, but its use in this study is experimental.
What is the full name of this clinical trial?
A PHASE III, INTERNATIONAL, MULTICENTER, RANDOMISED OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB VERSUS MMF IN PATIENTS WITH CHILDHOOD ONSET IDIOPATHIC NEPHROTIC SYNDROME