Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome

Phase 1

• Conditions: MedDRA version: 20.0 Level: LLT Classification code 10029168 Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Minimal Change Nephrotic Syndrome (MCNS)

• Registration Number: EUCTR2018-003437-15-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 148

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 =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
- Patients affiliated with the French health care system.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)
- 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
- Patients with a known allergy to steroid and its excipients or to Rituximab and its excipients
-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 IV) or severe, uncontrolled cardiac disease
- Patients who participate simultaneously in another drug trial
- Patients not willing or able to comply with the protocol requirements
- Patients who are under tutorship or curatorship

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified