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Completed
NCT05627557
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
Conditions: Childhood Idiopathic Nephrotic Syndrome
Sex: All
Ages: 2 Years – 25 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 85
Sponsor: Hoffmann-La Roche
Location: Lucile Packard Children's Hospital - Stanford Palo Alto California
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).
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS) before the age of 18 years
* Must be in complete remission defined by the absence of edema, UPCR \
Source: ClinicalTrials.gov (NCT05627557). StuddyBuddy aggregates publicly available trial information.
