Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

Steroid-Dependent Nephrotic Syndrome Clinical Trial

— RITUXIVIG  

Official title:

Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03560011
• Other study ID #: P160905J
• Secondary ID: 2017-000826-36
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: April 3, 2019
• Est. completion date: November 4, 2022

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

Description:

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 90
• Est. completion date: November 4, 2022
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

Inclusion Criteria:

• Childhood onset nephrotic syndrome (first flair <18 years)

• = 2 years old at inclusion

• Steroid-dependent:

• Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.

• Patient with at least 2 relapses including one under steroidsparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, Levamisole) or within 6 months of treatment withdrawal.

• or with frequent relapses:

· 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.

• with a relapse within 3 months prior to inclusion

• In remission: Protein-over-creatinine ratio = 0.2g/g (= 0.02g/mmol)

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, Hepatitis C or HIV infection;

• Pregnancy or breastfeeding.

• Patients with hyperprolinaemia,

• Known hypersensitivity to one of the study medication,

• Scheduled and not postponable injection of live attenuated vaccine

• Protected adults

• Patients with neutrophils < 1.5 G/L and/or platelets < 75 G/L

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Steroid-Dependent Nephrotic Syndrome
• Syndrome

Intervention

Drug:
• immunoglobulin IV
5 injections of immunoglobulin IV once a month during 5 months (2g/kg at M1, 1.5g/kg at M2 to M5, maximal dose 100g)

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of the first relapse	Relapse is defined as a protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher	24 months
Secondary	Time to first relapse		24 months
Secondary	Number of relapse over a 24 months follow-up		24 months
Secondary	Cumulative amount of corticosteroid over a 24 months follow-up		24 months
Secondary	Adverse events in each arm		24 months