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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560011
Recruitment Status : Suspended (Decision of Data Safety Monitoring Board)
First Posted : June 18, 2018
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Steroid-Dependent Nephrotic Syndrome Drug: immunoglobulin IV Phase 2 Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 Arms :

  • Rituximab (375 mg/m2)
  • Rituximab (375 mg/m2) followed by 5 injections of immunoglobulin IV once a month during 5 months (2g/kg at M1, 1.5g/kg at M2 to M5, maximal dise 100g)
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : January 7, 2021
Estimated Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Rituximab (375 mg/m²)
Single infusion of rituximab (375 mg/m²)
Experimental: Rituximab followed by 5 injections of immunoglobulin IV
Rituximab (375 mg/m²) followed by 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). Treatment duration : 6 months
 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)


Outcome Measures
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Primary Outcome Measures :
  1. The occurrence of the first relapse [ Time Frame: 24 months ]
    Relapse is defined as a protein to creatinine ratio of 2g/g of creatinine (0.2 g/mmol) or higher


Secondary Outcome Measures :
  1. Time to first relapse [ Time Frame: 24 months ]
  2. Number of relapse over a 24 months follow-up [ Time Frame: 24 months ]
  3. Cumulative amount of corticosteroid over a 24 months follow-up [ Time Frame: 24 months ]
  4. Adverse events in each arm [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560011


Locations
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France
Robert Debre Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Julien HOGAN, MD PhD APHP
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03560011    
Other Study ID Numbers: P160905J
2017-000826-36 ( EudraCT Number )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
 Urologic Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs