A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)

Inclusion criteria

• Understands and agrees to comply with the study procedures and provides informed consent as documented by signature
• Male or female patients aged 18 years or older at the time of consent
• Confirmed first episode of nephrotic syndrome at trial enrolment (serum albumin <30g/l and UPCR >3g/g creatinine (>300 mg/mmol) secondary to de novo MCD
• Histologically confirmed MCD (latest before randomization to Arm A or B)
• Only applies to women of childbearing potential (WOCBP):

• Has a high sensitivity negative urine/serum pregnancy test at screening
• Agrees to follow contraceptive guidance until 18 months after 2nd obinutuzumab treatment (if randomized to Arm B)
• Only applies to trial sites in France: Patients affiliated with the French health care system

Exclusion criteria

• MCD due to secondary causes, including malignancy of a type likely to be associated with MCD (i.e., lymphoproliferative disorders), or potentially related to treatment known to be associated with MCD occurrence (lithium, interferon, non-steroidal anti-inflammatory drugs)
• Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive
• Previous B cell depletion, independent of the agent and treatment target (i.e., CD20, CD38, etc.), within 18 months preceding baseline of the trial, or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets
• Previous cyclophosphamide within 6 months preceding baseline of the trial
• Treatment with Predniso(lo)ne within screening phase (before randomization)
• Evidence of current or past infection with Hepatitis B, C or Human Immunodeficiency Virus (HIV) (unless appropriate prophylaxis is given and no replicating virus is detected)
• Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug
• Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)
• Patient with a history of prior malignancy within 5 years before the first dose of study drug. Exceptions may apply for the following: malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer
• Pregnant or breast-feeding women
• Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks
• Previous/known hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro
• Co-enrolment in another clinical trial of an investigational medicinal product
• Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.