Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France11 sites in 1 countryChoose a country to see its sites
- Status
- Active, not recruiting
- Phase
- Phase 2/3
- People taking part
- 88 people enrolled
- Started
- 18 Oct 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- single infusion of Rituximab
- single infusion of Obinutuzumab
- Record updated
- 6 November 2026
Who can take part
- Age
- 3 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior treatment with Rituximab within 6 months
- Prior treatment with obinutuzumab at any time
- Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
- Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
- Primary or secondary steroid resistance nephrotic syndrome
- 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)
- Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
- 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
- Known hyperprolinemia
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Rituximab 375 mg/m2Existing treatment, for comparison
single infusion of Rituximab (375 mg/m2)
Treatment: single infusion of Rituximab
- Obinutuzumab 300 mg/1.73 m2Treatment being tested
single infusion of Obinutuzumab 300 mg/1.73 m2
Treatment: single infusion of Obinutuzumab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study
- Publications
- Record updated
- 6 November 2026