Rituximab from the first episode of Minimal Change Nephrotic Syndrome for preventing relapse risk in adult patients

Who can take part

• Patients aged ≥ 18 years
• First episode of Minimal Change Nephrotic Syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol, OR
• 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

Who cannot take part

• Previous administration of Rituximab therapy
• 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
• 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; Patient started on oral steroid therapy according to protocol dosage (1mg/kg) more than 4 weeks ago; Breastfeeding women; Severe heart failure (New York Heart Association Class III and IV) or severe or 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; 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 who have white blood cell count ≤4,000/mm3
• Patients who have platelet count ≤100,000/mm3
• Patient who have haemoglobin <9g/dL
• Patients who 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)