RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT03970577
• Date of registration: 15/04/2019
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome RIFIREINS
• Scientific title: Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial
• Date of first enrolment: July 29, 2020
• Target sample size: 148
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03970577
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Vincent AUDARD, MD, PhD

• Name: Vincent AUDARD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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 ßHCG 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 ßHCG at randomization (after 8 weeks of treatment by steroids)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Minimal Change Nephrotic Syndrome (MCNS)

Intervention(s)

Drug: Prednisone

Drug: Rituximab

Primary Outcome(s)

Incidence of MCNS relapse during the 12 months following randomization [Time Frame: 12 months following randomization]

Secondary Outcome(s)

Treatment Burden questionnaire (TBQ) © (Ravaud et al, 2012) [Time Frame: 4 weeks before randomization, 1 week after randomization and 16 weeks after randomization]

Severity of adverse events (AEs) and serious adverse events (SAEs) assessed by the CTCAE version 4.0 [Time Frame: 18 months]

Frequency of adverse events (AEs) and serious adverse events (SAEs) [Time Frame: 18 months]

The relapse rate [Time Frame: 18 months after randomization]

Type of adverse events (AEs) and serious adverse events (SAEs) [Time Frame: 18 months]

Secondary ID(s)

2018-003437-15

P170922J

Source(s) of Monetary Support

Please refer to primary and secondary sponsors