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
Status: Active_not_recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 25
Healthy Volunteers: f
View:
• 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 \<= 0.2 g/g at screening and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
• Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
• Participants having received cyclophosphamide in the 6 months prior to randomization must have experienced at least 1 relapse subsequent to cyclophosphamide discontinuation
• Estimated glomerular filtration rate (eGFR) within normal range for age
• For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception, during the treatment period and for 18 months after the final dose of obinutuzumab and for 6 weeks after the final dose of MMF
• For males: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of MMF
Locations
United States
California
Lucile Packard Children's Hospital - Stanford
Palo Alto
Florida
Memorial Healthcare System
Hollywood
Nicklaus Children's Hospital
Miami
Nemours Children's Hospital
Orlando
University of South Florida
Tampa
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta
North Carolina
Levine Children's Hospital
Charlotte
New Jersey
Hackensack University Medical Center
Hackensack
Utah
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City
Virginia
University of Virginia Health System
Charlottesville
Other Locations
Belgium
UZ Gent
Ghent
Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José Do Rio Preto
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo
China
Peking University First Hospital
Beijing
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
The children's hospital , Zhejiang university school of medicine
Hangzhou
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa
Ospedale Infantile Regina Margherita - INCIPIT - PIN
Turin
Japan
Tokyo Metropolitan Children's Medical Center
Fuchu-shi
Hokkaido University Hospital
Hokkaido
Hyogo prefectural Kobe Children's Hospital
Hyogoken
Kobe University Hospital
Kobe
Shiga University Of Medical Science Hospital
Ōtsu
Kitasato University Hospital
Sagamihara-shi
Dokkyo Medical University Hospital
Shimotsuga-gun
National Center for Child Health and Development
Tokyo
Yokohama City University Medical Center
Yokohama
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Dzieciecy Szpital Kliniczny UCK WUM
Warsaw
Spain
Hospital Universitario Cruces
Barakaldo
Hospital Sant Joan de Deu - PIN
Espluges De Llobregat
Time Frame
Start Date:2023-03-29
Completion Date:2026-09-04
Participants
Target number of participants:85
Treatments
Experimental: Obinutuzumab (Group A)
Participants in Group A will receive obinutuzumab 1000 milligrams (mg) (or 20 mg/ kilogram \[kg\] for participants \<45 kg) administered by intravenous (IV) infusion on Days 1, 15, 168 (Week 24), and 182 (Week 26).
Active_comparator: MMF (Group B)
Participants in Group B will receive oral MMF 600 mg/m\^2 twice a day (BID) (target 1200 mg/m2/day in divided doses, maximum 2 g/day) to Week 52.