Last updated 3 months ago
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
80 patients around the world
Available in Spain, United States, Brazil
Hoffmann-La Roche
1Research sites
80Patients around the world
This study is for people with
Idiopathic Nephrotic Syndrome
Requirements for the patient
To 25 Years
All Gender
Medical requirements
- Diagnosis of frequently relapsing nephrotic syndrome (FRNS) or steroid dependent nephrotic syndrome (SDNS) before the age of 18 yearsMust 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 randomizationMust 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 relapsesParticipants having received cyclophosphamide in the 6 months prior to randomization must have experienced at least 1 relapse subsequent to cyclophosphamide discontinuationEstimated glomerular filtration rate (eGFR) within normal range for ageFor 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 MMFFor 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
- Secondary nephrotic syndromeHistory of steroid resistant nephrotic syndromeHistory of genetic defects known to directly cause nephrotic syndromeTreatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomizationPregnancy 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 MMFFemales 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 randomizationHistory of organ or bone marrow transplantParticipation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drugIntolerance or contraindication to study therapiesParticipants 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 durationParticipants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the studyActive 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 randomizationHistory of or currently active primary or secondary immunodeficiency, including known history of human immunodeficiency virus (HIV) infection and other severe Immunodeficiency blood disordersHistory of progressive multifocal leukoencephalopathyHistory of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ within the past 5 yearsMajor surgery requiring hospitalization during the 4 weeks prior to screening or during screeningHigh risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusionsEvidence 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 disordersCurrently active alcohol or drug abuse or history of alcohol or drug abuse
Sites
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyINShore
SponsorHoffmann-La Roche
Conditions
Requirements
To 25 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05627557
