clinical trial · NCT05627557
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
Hoffmann-La Roche·phase3·active not recruiting·n = 85
Childhood Idiopathic Nephrotic SyndromeObinutuzumabMMFPrednisoneMethylprednisoloneAcetaminophen/ ParacetamolDiphenhydramine Hydrochloride
brief summary
This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged \>= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).
started
Mar 29, 2023
primary completion
Sep 4, 2025
completion
Sep 4, 2026
last updated
Dec 15, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol