Rituximab from the first episode of Minimal Change Nephrotic Syndrome for preventing relapse risk in adult patients
- Conditions
- Minimal Change Nephrotic Syndrom
- Registration Number
- 2024-516102-36-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
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) to prevent relapse after 12 months of follow-up
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 148
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
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
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)
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method The relapse rate at 18 months of follow-up after randomization The relapse rate at 18 months of follow-up after randomization
The type, frequency and the severity of adverse events (AEs) and serious adverse events (SAEs) The type, frequency and the severity of adverse events (AEs) and serious adverse events (SAEs)
The treatment burden assessed with the Treatment Burden Questionnaire The treatment burden assessed with the Treatment Burden Questionnaire
To assess potential risk factors of relapse, the following explanatory variables will be recorded (demographics, clinical characteristics, biological variables, renal pathologic findings) To assess potential risk factors of relapse, the following explanatory variables will be recorded (demographics, clinical characteristics, biological variables, renal pathologic findings)
Trial Locations
- Locations (15)
Assistance Publique Hopitaux De Paris
🇫🇷Boulogne-Billancourt, France
Centre Hospitalier De Valenciennes
🇫🇷Valenciennes, France
Centre Hospitalier Universitaire De Nantes
🇫🇷Nantes, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷Bordeaux, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg, France
Centre Hospitalier Universitaire Rouen
🇫🇷Rouen Cedex, France
Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Centre Hospitalier Intercom Gregoire
🇫🇷Montreuil, France
Hospital Foch
🇫🇷Suresnes, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil Essonnes, France
Scroll for more (5 remaining)Assistance Publique Hopitaux De Paris🇫🇷Boulogne-Billancourt, FranceMohamad ZaidanSite contact0145212674mohamad.zaidan@aphp.frAlexandre KarrasSite contact0156093760alexandre.karras@aphp.frBertrand KNEBELMANNSite contact0144495450bertrand.knebelmann@aphp.frVincent AudardSite contact0149814446vincent.audard@aphp.frEric DaugasSite contact0140257101eric.daugas@aphp.frJean-Jacques BoffaSite contact0156017043jean-jacques.boffa@aphp.frZiad MassySite contact0149095635ziad.massy@aphp.fr