Comparing Obinutuzumab and Rituximab for Treating Nephrotic Syndrome in Children
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study
This study is testing if a new treatment called obinutuzumab can help children with nephrotic syndrome have fewer relapses and need less medication compared to the standard treatment, rituximab.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | Rituximab, obinutuzumab, cyclophosphamide |
| Locations | 1 site (Paris) |
| Trial ID | NCT05786768 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a single infusion of obinutuzumab compared to rituximab in children aged 3 to 18 years with steroid-dependent or frequently relapsing nephrotic syndrome. The study aims to determine if obinutuzumab, a second-generation monoclonal antibody, can provide better outcomes by reducing the risk of relapse and minimizing the need for additional immunosuppressive medications. Participants will be randomly assigned to receive either treatment in a double-blind manner, ensuring unbiased results. The trial is being conducted at Robert Debre Hospital in Paris.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 years with steroid-dependent or frequently relapsing nephrotic syndrome.
Not a fit: Patients with secondary causes of nephrotic syndrome or those who are steroid-resistant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved long-term remission rates for children suffering from nephrotic syndrome.
How similar studies have performed: Previous studies have shown success with rituximab in similar conditions, but the use of obinutuzumab represents a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 3 and 18 years * Steroid dependant Nephrotic Syndrome defined as: * 2 or more relapses during steroids or within 2 weeks following discontinuation. * 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 * 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 Exclusion Criteria: * Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis) * 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 * 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)
Where this trial is running
Paris
- Robert Debre Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Claire DOSSIER, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Claire DOSSIER, MD
- Email: claire.dossier@aphp.fr
- Phone: +33140032467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.