Actively Recruiting
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-11-09
88
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 18 years
- Steroid dependent nephrotic syndrome with 2 or more relapses during steroids or within 2 weeks after stopping steroids
- 2 or more relapses including one while on steroid-sparing drugs or within 6 months after stopping these treatments
- Frequent relapsing nephrotic syndrome with 2 or more relapses within 6 months after first remission
- Frequent relapsing nephrotic syndrome with 3 or more relapses in any 12-month period
- Last relapse occurred within 3 months before joining the study
- In remission with 3 consecutive urine tests showing no protein at randomization
- Up-to-date vaccination according to French recommendations
- Informed consent from parents or guardians
You will not qualify if you...
- Secondary causes of nephrotic syndrome like membranous nephropathy, IgA nephropathy, or lupus nephritis
- Steroid resistant nephrotic syndrome (primary or secondary)
- Rituximab treatment within 6 months before the study
- Previous obinutuzumab treatment at any time
- CD20+ B-cell count less than 2.5%
- Low neutrophils (<1.5 G/L) or low platelets (<75 G/L)
- Kidney function (GFR) below 80 ml/min/1.73 m2
- Weight below 16 kg
- History of severe infections such as tuberculosis, hepatitis B or C, HIV, or progressive multifocal leukoencephalopathy (LEMP)
- History of cancer
- Uncontrolled infections (viral, bacterial, fungal)
- Vaccination with live vaccine within 4 weeks before randomization
- Known hyperprolinemia
- Allergy or hypersensitivity to obinutuzumab, rituximab, murine proteins, or excipients
- Pregnancy, breastfeeding, or unwillingness to use contraception during 18 months after treatment
- No medical insurance coverage or legal beneficiary status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Robert Debre Hospital
Paris, France, 75019
Actively Recruiting
Research Team
C
Claire DOSSIER, MD
CONTACT
J
Julien HOGAN, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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