Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05786768
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Steroid-Dependent Nephrotic Syndrome
  • Steroid-Sensitive Nephrotic Syndrome

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • single infusion of Rituximab — DRUG
    single infusion of Rituximab 375 mg/m2
  • single infusion of Obinutuzumab — DRUG
    single infusion of Obinutuzumab 300mg/1.73 m2

Study Details

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 Dates

Start date
Oct 18, 2023
Status verified
Jan 2023
Primary completion
Oct 18, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab 375 mg/m2
    single infusion of Rituximab (375 mg/m2)
  • Experimental: Obinutuzumab 300 mg/1.73 m2
    single infusion of Obinutuzumab 300 mg/1.73 m2

Primary Outcome Measure

Occurrence of a relapse within 12 months following the initiation of treatment [ Time Frame: 12 months ]

Central Contacts