RITUXIMAB for Minimal change nephrotic syndrome

Inclusion criteria

• {"criterion_text":"- Patients aged ≥ 18 years\n- First episode of Minimal Change Nephrotic Syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol, OR\n- 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\n- Signed informed consent to participate in the study\n- Patients who are affiliated with the French health care system"}

Exclusion criteria

• {"criterion_text":"- Previous administration of Rituximab therapy\n- Patient started on oral steroid therapy according to protocol dosage (1mg/kg) more than 4 weeks ago\n- 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)\n- Patients with acute infections or chronic active infections\n- Positive serological screening test for HIV, B or C hepatitis\n- Positive immunological tests for antinuclear and anti-DNA antibodies\n- Usual contraindication to steroid or Rituximab\n- Immunosuppressed patients, patients with a severe immune deficit\n- Patients with hypersensitivity to a monoclonal antibody or biological agents\n- 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\n- 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\n- Patients who have white blood cell count ≤4,000/mm3\n- Patients who have platelet count ≤100,000/mm3\n- Patient who have haemoglobin <9g/dL\n- Patients who SGOT or SGPT or bilirubin level greater than 3 times the upper limit of normal\n- Patients who have serum creatinine level >150 µmol/l,\n- Patients with active cancer or recent cancer (<5 years)\n- 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\n- Women who are pregnant (positive βHCG at inclusion), or who plan to become pregnant whilst in the trial\n- Breastfeeding women\n- Severe heart failure (New York Heart Association Class III and IV) or severe or uncontrolled cardiac disease\n- Patients who participate simultaneously in another interventional trial\n- Patients not willing or able to comply with the protocol requirements\n- Patients who are under tutorship or curatorship"}

Primary endpoints

• {"endpoint_text":"- Incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission","definition_or_measurement_approach":"Relapse defined as recurrence of nephrotic syndrome with UPCR ≥ 300 mg/mmol and albumin < 30 g/L in a patient previously in complete remission; measured during 12 months following randomization"}

Secondary endpoints

• {"endpoint_text":"- The relapse rate at 18 months of follow-up after randomization","definition_or_measurement_approach":"Relapse rate expressed as number of relapses per person-year, assessed up to 18 months after randomization"}
• {"endpoint_text":"- The type, frequency and the severity of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"Collection and classification of AEs and SAEs during 18 months of follow-up; type, frequency and severity recorded"}
• {"endpoint_text":"- The treatment burden assessed with the Treatment Burden Questionnaire","definition_or_measurement_approach":"Treatment burden measured using the Treatment Burden Questionnaire at specified timepoints"}
• {"endpoint_text":"- To assess potential risk factors of relapse, the following explanatory variables will be recorded (demographics, clinical characteristics, biological variables, renal pathologic findings)","definition_or_measurement_approach":"Recording of demographic, clinical, biological and renal pathology variables to assess association with relapse at 12 and 18 months"}

France

Earliest CTIS Part Ii Submission Date

09-08-2024

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

201

Number Of Sites

21

Number Of Participants

148

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France