Childhood Nephrotic Syndrome
Conditions
Interventions
Obinutuzumab: Participants in Obinutuzumab (Group A) will receive obinutuzumab 1000 milligrams (mg) (or 20 mg/ kilogram [kg] for participants <45 kg) administered by intravenous (IV) infusion on Days
Sponsors
Will Pendergraft, M.D., Ph.D.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of FRNS or 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 -Estimated glomerular filtration rate (eGFR) within normal range for age
Exclusion criteria
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 -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Percentage of Participants with Sustained Complete Remission at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy, Phamacokinetics, Phamacodynamics -Overall Relapse Free Survival (RFS) [Time Frame: At Week 52] -Probability of RFS at Week 52 [Time Frame: At Week 52] -Cumulative corticosteroid dose (prednisone or equivalent adjusted for time on study)[Time Frame: At Week 52] -Number of relapses on randomized study treatment[Time Frame: At Week 52] | — |
Countries
Belgium, Brazil, China, France, Germany, Italy, Japan, Poland, Spain, Turkey, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed