Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Recruiting now · Phase 2/Phase 3
Conditions studied: Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
In brief
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).
Key facts
- Study ID
- NCT05786768
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 88
- Starts
- 2023-10-18
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2023-11-09
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Robert Debre Hospital — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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