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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Obinutuzumab will be administered as per schedule specified in the respective arm.
MMF will be administered as per schedule specified in the respective arm.
Participants taking prednisone or equivalent at randomization will follow a guided tapering schedule to reach the goal of 0mg/day by Weeks 4-6 (and no later than Week 8 following randomization and continue without prednisone through Week 52.
Percentage of Participants with Sustained Complete Remission at 1 year
Time frame: At Week 52
Overall Relapse-free Survival (RFS)
Time frame: At Week 52
Probability of RFS at Week 52
Time frame: At Week 52
Cumulative Corticosteroid Dose
Time frame: At Week 52
Number of Relapses
Time frame: At Week 52
Percentage of Participants Experiencing Edema Associated Relapse
Time frame: At Week 52
Percentage of Participants with Sustained Complete Remission
This outcome measure will be assessed at primary analysis
Time frame: Week 52 to Week 76
Mean Change in "General Fatigue" Domain of Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale Total Score
Time frame: Baseline to Week 52
Mean Change in "Physical Functioning" Domain of PedsQL Quality of Life Inventory
Time frame: Baseline to Week 52
Mean Change in Cure Glomerulonephropathy (CureGN) Edema Scale
Time frame: Baseline to Week 52
Percentage of Participants with Adverse Events (AEs)
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Methylprednisolone 80 mg (or 1.5 mg/kg if \</=45 kg) IV will be administered as premedication prior to infusions.
Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions.
Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, United States
Memorial Healthcare System
Hollywood, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
...and 29 more locations
Time frame: Baseline to Week 52
Serum Concentrations of Obinutuzumab
Time frame: At Days 1, 15 28, 84, 168, 182, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364)
Percentage of Participants Achieving B Cell Depletion Highly Sensitive Flow Cytometry (HSFC)
Time frame: At Days 1, 15, 28, 84, 168, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364)
Total Peripheral B Cell and B Cell Subsets (e.g., Memory B Cells) Counts and Change from Baseline
Time frame: At Days 1, 15, 28, 84, 168, 224, 364, and at Early Study Discontinuation Visit (unscheduled visit at the time of discontinuation from study, any time between Day 1 and Day 364)