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Efficacy and Safety of Obinutuzumab versus Rituximab in childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : à double-blind multicenter randomized controlled study
EU CTIS ID: 2024-514240-93-00
What this study is testing
To assess the superiority of one infusion of obinutuzumab compared to one infusion of rituximab on the relapse-free survival at 12-months.
- Phase II and Phase III (Integrated)
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
- Age ≥ 3 and < 18 ans
- Steroid dependant Nephrotic Syndrome defined as: • 2 or more relapses during steroids or within 2 weeks following discontinuation. • OR 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal . OR Frequent Relapsing Nephrotic Syndrome defined as: • 2 or more relapses within 6 months following first remission or 3 or more relapses within any 12-month period
- Last relapse within 3 months prior to inclusion
- In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
- Vaccination schedule in accordance with the current recommendations in France
- -Informed consent from parents
You likely can't join if
- Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
- History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
- Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
- Known hyperprolinemia
- Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
- Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
See the full eligibility criteria
- Age ≥ 3 and < 18 ans
- Steroid dependant Nephrotic Syndrome defined as: • 2 or more relapses during steroids or within 2 weeks following discontinuation. • OR 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal . OR Frequent Relapsing Nephrotic Syndrome defined as: • 2 or more relapses within 6 months following first remission or 3 or more relapses within any 12-month period
- Last relapse within 3 months prior to inclusion
- In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
- Vaccination schedule in accordance with the current recommendations in France
- -Informed consent from parents
- Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
- History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
- Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
- Known hyperprolinemia
- Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
- Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
- Patient without medical insurance coverage (beneficiary or legal)
- Primary or secondary steroid resistance nephrotic syndrome
- Prior treatment with Rituximab within 6 months
- Prior treatment with obinutuzumab at any time
- CD20+ B-cell count < 2.5%
- Patient with neutrophils < 1.5 G/L and/or platelets < 75 G/L
- GFR < 80 ml/min/1.73m2
- - Weight <16kg
- History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
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, 0-17 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.