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A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
Sponsor: Hoffmann-La Roche
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).
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
Key Details
Gender
All
Age Range
2 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2023-03-29
Completion Date
2026-09-04
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Obinutuzumab will be administered as per schedule specified in the respective arm.
MMF
MMF will be administered as per schedule specified in the respective arm.
Prednisone
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.
Methylprednisolone
Methylprednisolone 80 mg (or 1.5 mg/kg if \</=45 kg) IV will be administered as premedication prior to infusions.
Acetaminophen/ Paracetamol
Acetaminophen 15 mg/kg (maximum dose 1000 mg) will be administered PO as premedication prior to infusions.
Diphenhydramine Hydrochloride
Diphenhydramine HCl 0.5-1 mg/kg (maximum dose 50 mg) will be administered PO or IV as premedication prior to infusions.
Locations (39)
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
UZ Gent
Ghent, Belgium
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The children's hospital , Zhejiang university school of medicine
Hangzhou, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Xi'an Children's Hospital
Xi'an, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, China
Chu Toulouse
Toulouse, Haute-Garonne, France
Hopital Femme Mere Enfants
Bron, France
Hopital Henri Mondor
Créteil, France
Hopital Robert Debre
Paris, France
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, Italy
Ospedale Infantile Regina Margherita - INCIPIT - PIN
Turin, Piedmont, Italy
Tokyo Metropolitan Children's Medical Center
Fuchu-Shi, Japan
Hokkaido University Hospital
Hokkaido, Japan
Hyogo prefectural Kobe Children's Hospital
Hyogoken, Japan
Kobe University Hospital
Kobe, Japan
Shiga University Of Medical Science Hospital
Ōtsu, Japan
Kitasato University Hospital
Sagamihara-Shi, Japan
Dokkyo Medical University Hospital
Shimotsuga-Gun, Japan
National Center for Child Health and Development
Tokyo, Japan
Yokohama City University Medical Center
Yokohama, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Dzieciecy Szpital Kliniczny UCK WUM
Warsaw, Poland
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain