RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Minimal Change Nephrotic Syndrome (MCNS)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will be a single stage phase IIb, randomized, open-label, parallel group, in a 1:1 ratio, active controlled, multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week (375mg/m2) from initial episode of MCNS in adults. The control arm is a standard regimen of oral steroid alone (progressively tapered within 24 weeks). At inclusion, all patients will receive oral steroid therapy (Prednisone, 1mg/kg/day, maximum 80 mg/day). For patients without complete remission after 4 weeks of treatment, prednisone will be continued at the same dose until the 8th week. For patients with complete remission after 4 weeks of treatment, doses of prednisone will be progressively reduced between the 4th and the 8th week (0.06 mg/kg by week). Patients who reach complete remission by 8 weeks after inclusion will be randomized at this time to receive either Rituximab (experimental group) or the standard steroid regimen (control group).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03970577
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Vincent AUDARD Assistance Publique - Hôpitaux de Paris
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