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Tests treatment safety and results for Minimal Change Disease (MCD)
Official title A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)
ClinicalTrials.gov ID: NCT07710157
What this study is testing
What is Obinutuzumab Injection?
Obinutuzumab Injection is an investigational medicine, being studied as a potential treatment for minimal change disease (mcd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- OBELIX-NEPHROSIS (NS) The goal of this clinical trial is to learn if obinutuzumab works to treat minimal change disease in adults. It will also learn about the safety of drug obinutuzumab.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 \ 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):
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...
- 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...
- 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...
See the full eligibility 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 \ 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 assigned by chance to Arm B)
- Only applies to trial sites in France: Patients affiliated with the French health care system
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Innsbruck, Austria
- Vienna, Austria
- Nice, France
- Paris, France
- Hamburg, Germany
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 study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Innsbruck, Austria; Vienna, Austria; Nice, France; Paris, France; Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.