A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore)
Childhood Idiopathic Nephrotic Syndrome
About this trial
This is an interventional treatment trial for Childhood Idiopathic Nephrotic Syndrome
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 <= 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: Secondary nephrotic syndrome 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
Sites / Locations
- Lucile Packard Children's Hospital - StanfordRecruiting
- Memorial Healthcare SystemRecruiting
- Children's Healthcare of Atlanta Center for Advanced PediatricsRecruiting
- Children's Mercy HospitalRecruiting
- Hackensack University Medical CenterRecruiting
- UNC Hospitals Outpatient Center at EastowneRecruiting
- University of Utah - Primary Children's Hospital - PPDSRecruiting
- University of Virginia Health SystemRecruiting
- Hôpital Universitaire des Enfants Reine FabiolaRecruiting
- UZ GentRecruiting
- Chu ToulouseRecruiting
- Hopital Femme Mere EnfantsRecruiting
- Hopital Henri MondorRecruiting
- CHU Montpellier- Hopital Arnaud de VIlleneuveRecruiting
- Hopital Necker - Enfants MaladesRecruiting
- Hopital Robert DebreRecruiting
- Hokkaido University HospitalRecruiting
- Hyogo prefectural Kobe Children's HospitalRecruiting
- Kobe University HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Kitasato University HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- Shiga University Of Medical Science HospitalRecruiting
- National Center for Child Health and DevelopmentRecruiting
- Tokyo Metropolitan Children's Medical CenterRecruiting
- Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
- In-VIVO Osrodek Badan KlinicznychRecruiting
- Uniwersyteckie Centrum KliniczneRecruiting
- Dzieciecy Szpital Kliniczny UCK WUMRecruiting
- Hospital Universitario Marques de ValdecillaRecruiting
- Hospital Universitario CrucesRecruiting
- Hospital Sant Joan de Deu - PINRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Obinutuzumab (Group A)
MMF (Group B)
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).
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.