Efficacy of immunoglobulins in pediatric early-onset corticosteroid nephrotic syndrome

Efficacy and safety of immunoglobulin associated with rituximab versus rituximab alone in Childhood-Onset steroid-dependent nephrotic syndrome - RITUXIVIG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000826-36-FR

Enrollment

Registered

2018-03-21

Start date

2018-05-17

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood-Onset steroid-dependent nephrotic syndrome MedDRA version: 20.1 Level: PT Classification code 10029164 Term: Nephrotic syndrome System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Privigen Product Name: Privigen Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Immunoglobulines humaines normales Other descriptive name: Privigen 100 mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Childhood onset nephrotic syndrome (first flair at age> 2 years and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with steroid-resistant nephrotic syndrome; - Patients with genetic nephrotic syndrome; - Patients previously treated with rituximab; - Patients with no affiliation to a social security scheme (beneficiary or legal); - Prior hepatitis B infection; - Pregnancy or breastfeeding. - Patients with hyperprolinaemia, - Known hypersensitivity to one of the study medication, - Scheduled and not postponable injection of live attenuated vaccine

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of a single infusion of rituximab followed by immunoglobulin injections (once a month during 5 months) on the occurrence of the first relapse within 24 months following the initiation of treatment in patient with childhood onset Steroid-dependent nephrotic syndrome compared to a single infusion of rituximab.;Secondary Objective: 1/ To assess the impact of a treatment with rituximab followed by intravenous immunoglobulin injection compared to a single infusion of rituximab on: - Time to first relapse - Number of relapse over a 24 months follow-up - Cumulative amount of corticosteroid over a 24 months follow-up - Initiation of a new immunosuppressive therapy 2/ To assess the demographics, clinical and biological risk factors of relapse. 3/ To access the adverse events in each arm. ;Primary end point(s): The primary outcome is the occurrence of the first relapse within 24 months following the initiation of treatment. Relapse is defined as: - A protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher. Secondary assessment criterion : - Time to first relapse; - Number of relapse over a 24 months follow-up; - Cumulative amount of corticosteroid over a 24 months' follow-up; - Initiation of a new immunosuppressive therapy - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: To assess the effect of a single infusion of rituximab followed by immunoglobulin injections (once a month during 5 months) on the occurrence of the first relapse within 24 months following the initiation of treatment in patient with childhood onset Steroid-dependent nephrotic syndrome compared to a single infusion of rituximab.;Secondary Objective: 1/ To assess the impact of a treatment with rituximab followed by intravenous immunoglobulin injection compared to a single infusion of rituximab on: - Time to first relapse - Number of relapse over a 24 months follow-up - Cumulative amount of corticosteroid over a 24 months follow-up - Initiation of a new immunosuppressive therapy 2/ To assess the demographics, clinical and biological risk factors of relapse. 3/ To access the adverse events in each arm. ;Primary end point(s): The primary outcome is the occurrence of the first relapse within 24 months following the initiation of treatment. Relapse is defined as: - A protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher. Secondary assessment criterion : - Time to first relapse; - Number of relapse over a 24 months follow-up; - Cumulative amount of corticosteroid over a 24 months' follow-up; - Initiation of a new immunosuppressive therapy - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia;Timepoint(s) of evaluation of this end point: 24 months

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Secondary

Measure	Time frame
Secondary end point(s): - Time to first relapse from the beginning of treatment; - Number of relapse occurring during the 24 months' follow-up period; - Cumulative amount of corticosteroid taken during the 24 months' follow-up: it is calculated as the cumulative dose of corticosteroid for the enrolment episode plus the cumulative dose of corticosteroid for each relapse; - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Secondary end point(s): - Time to first relapse from the beginning of treatment; - Number of relapse occurring during the 24 months' follow-up period; - Cumulative amount of corticosteroid taken during the 24 months' follow-up: it is calculated as the cumulative dose of corticosteroid for the enrolment episode plus the cumulative dose of corticosteroid for each relapse; - Adverse events during the study period such as infectious complications, treatment tolerance, nausea, neutropenia;Timepoint(s) of evaluation of this end point: 24 months

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

sophie.courtial-destembert@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026