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A randomized controlled, two-arm (1:1 ratio) Phase IIa trial to assess the efficacy and safety of obinutuzumab in treating adults with de novo minimal change disease
EU CTIS ID: 2025-520641-69-00
What this study is testing
To compare the efficacy of obinutuzumab versus standard of care (standard regimen of oral glucocorticoid therapy; progressively tapered over 24 weeks) in the management of newly onset biopsy-proven minimal change disease in its non-inferiority and further in its superiority.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (>300mg/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): 5a) Has a high sensitivity negative urine/serum pregnancy test at screening 5b) 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
You likely can't join if
- 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)
- 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
- Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
See the full eligibility criteria
Who can join
- 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 (>300mg/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): 5a) Has a high sensitivity negative urine/serum pregnancy test at screening 5b) 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
What rules you out
- 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)
- 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
- Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.