NCT05786768 Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
| NCT ID | NCT05786768 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Steroid-Dependent Nephrotic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2027-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 88 participants in total. It began in 2023-10-18 with a primary completion date of 2027-10-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).
Eligibility 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)
Contact & Investigator
Claire DOSSIER, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05786768 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Steroid-Dependent Nephrotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05786768 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05786768 currently recruiting?
Yes, NCT05786768 is actively recruiting participants. Contact the research team at claire.dossier@aphp.fr for enrollment information.
Where is the NCT05786768 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05786768 clinical trial?
NCT05786768 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Claire DOSSIER, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 88 participants.