A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
NCT ID: NCT05627557
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
85 participants
INTERVENTIONAL
2023-03-29
2026-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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.
Obinutuzumab
Obinutuzumab will be administered as per schedule specified in the respective arm.
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.
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.
MMF
MMF will be administered as per schedule specified in the respective arm.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of steroid resistant nephrotic syndrome
* History of genetic defects known to directly cause nephrotic syndrome
* Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
* Pregnancy or breastfeeding or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab, or within 6 weeks after the final dose of MMF
* Females of childbearing potential, including those who have had a tubal ligation, must have a negative serum pregnancy test result within 28 days prior to initiation of study treatment and a negative urine pregnancy test at Day 1, prior to randomization
* History of organ or bone marrow transplant
* Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug
* Intolerance or contraindication to study therapies
* Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
* Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study
* Active infection of any kind or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
* History of or currently active primary or secondary immunodeficiency, including known history of human immunodeficiency virus (HIV) infection and other severe Immunodeficiency blood disorders
* History of progressive multifocal leukoencephalopathy
* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ within the past 5 years
* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
* High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
* Evidence of any significant or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant's participation, including but not limited to nervous system, respiratory, cardiac, hepatic, endocrine, malignant, or gastrointestinal disorders
* Currently active alcohol or drug abuse or history of alcohol or drug abuse
2 Years
25 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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References
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Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
Other Identifiers
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2022-000369-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505140-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
WA43380
Identifier Type: -
Identifier Source: org_study_id
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