Minimal Change Nephrotic Syndrome (MCNS) MedDRA version: 20.0 Level: LLT Classification code 10029168 Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis System Organ Class: 100000004857
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient aged = 18 years - First episode of Minimal change nephrotic syndrome defined as albumin level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous administration of Rituximab therapy - MCNS resulting from a secondary process (lymphoid disorders or malignant disease) or potentially related to treatment known to be associated with MCNS occurrence (Lithium, Interferon, non-steroidal anti-inflammatory drugs) - Positive serological screening test for HIV, B or C hepatitis - Positive immunological tests for antinuclear and anti-DNA antibodies - Usual contraindication to steroid or Rituximab - Patients with a known allergy to steroid and its excipients or to Rituximab and its excipients -Females of childbearing potential who don’t have an effective method of birth control during the study and during the next 12 months after treatment stop -Women who are pregnant (positive ßHCG at inclusion), or who plan to become pregnant whilst in the trial - Breastfeeding women - Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease - Patients who participate simultaneously in another drug trial - Patients not willing or able to comply with the protocol requirements - Patients who are under tutorship or curatorship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate, from initial episode of MCNS in adults, once complete remission occurred, the efficacy of Rituximab (two injections separated by one week 375mg/m2, with definitive steroids withdrawal after 9 weeks of treatment) compared to the standard regimen of oral steroid alone (progressively tapered within 24 weeks) to prevent relapse after 12 months of follow-up.; Secondary Objective: The secondary objectives are to compare between the two arms: - The relapse rate (number of relapses per person-year) at 12 and 18 months after randomization - The time between randomization and relapse (with time points 12 and 18 months after randomization) - The type, frequency and the severity of adverse events and serious adverse events during 12 and 18 months - The treatment burden that will be assessed at Week-4 before randomization, one week and 16 weeks after randomization - The demographics, clinical and/or biological risk factors of relapse at 12 and 18 months follow-up. ; Primary end point(s): Primary efficacy endpoint The incidence of relapse will be analysed using survival analysis. A Cox proportional hazards model will be performed. The incidence of relapse at 12 months follow –up and its 95% confidence interval will be estimated in each study arm. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints The incidence of relapse at 18 months will be analysed using the same methodology than at 12 months time point. ;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
France
Contacts
Public ContactDRCI - Hôpital Saint Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Outcome results
None listed