RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome (RIFIREINS)
Minimal Change Nephrotic Syndrome (MCNS)
About this trial
This is an interventional treatment trial for Minimal Change Nephrotic Syndrome (MCNS) focused on measuring Minimal Change Nephrotic syndrome, Rituximab, Relapse rate
Eligibility Criteria
Inclusion Criteria:
- Patient aged ≥ 18 years
- First episode of Minimal change nephrotic syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio (UCPR) ≥ 300mg/mmol
- Biopsy-proven MCNS defined on renal biopsy examination by the presence of minimal change glomerular lesions and absence of segmental sclerosis by light microscopy, negative immunofluorescence, or presence of IgM deposits into the mesangium
- Signed informed consent to participate in the study
- Patients who are affiliated with the French health care system
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)
- Patients with acute infections or chronic active infections
- 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
- Immunosuppressed patients, patients with a severe immune deficit
- Patients with hypersensitivity to a monoclonal antibody or biological agents
- Patients with a known allergy to steroid and its excipients or to Rituximab and its excipients or to acetaminophen and its excipients or to cetirizine and its excipients or to protein of murine origin
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- Patients who have white blood cell count ≤4,000/mm3,
- Patients who have platelet count ≤100,000/mm3,
- Patients who have haemoglobin level <9g/dL,
- Patients who have SGOT or SGPT or bilirubin level greater than 3 times the upper limit of normal
- Patients who have serum creatinine level >150 µmol/l,
- Patients with active cancer or recent cancer (<5 years),
- 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 βHCG at inclusion), or who plan to become pregnant whilst in the trial
- Breastfeeding women
- Severe heart failure (New York Heart Association Class III and IV) or severe, uncontrolled cardiac disease
- Patients who participate simultaneously in another interventional trial
- Patients not willing or able to comply with the protocol requirements
- Patients who are under tutorship or curatorship
Non randomization criteria
- Absence of complete remission after 8 weeks of treatment by steroids (CR is defined as albumin level > 30 g/L and urine protein/creatinine ratio <30mg/mmol ).
- Positive βHCG at randomization (after 8 weeks of treatment by steroids)
Sites / Locations
- AUDARDRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rituximab treatment
Oral steroid treatment
Two injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks)
The patients will continue exclusive oral steroid treatment, that will be progressively tapered, for a total of 24 weeks (by taking into account the initial oral steroid therapy administered during 8 weeks and the oral steroid treatment given after randomization). Each patient will be followed up until 18 months after randomization. The patient will have study visits at inclusion, 4 weeks and 8 weeks after inclusion. At the time of randomization, patients who will have reached CR of MCNS will be allocated in test or control group and will be followed up similarly: visits at 1, 4, 16, 24 weeks, 12 and 18 months after randomization.