{
  "abstract": "Introduction There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.Methods and analysis We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m 2) and in the control group, the patients receive 1 infusion of RTX (375 mg/m2). The primary outcome of the study is the occurrence of the first relapse within 12 months following the initiation of treatment and secondary outcomes include the time to first relapse, the total number of relapses during the 24-month follow-up period, and any adverse events such as infusion-related complications, infectious complications, hypogammaglobulinaemia and neutropenia.Ethics and dissemination The study has been approved by the ethics committee (Comité de Protection des Personnes) of Sud Méditerrannée 2 and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.Trial registration number NCT05786768.Eudract N° 2022-003336-59.",
  "authors": [
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Robert-Debré Mother-Child University Hospital, Paris, Île-de-France, France"
      ],
      "name": "Claire Dossier"
    },
    {
      "affiliations": [
        "Paediatric Nephrology, Hôpital Femme Mère Enfant, Bron, Auvergne-Rhône-Alpes, France"
      ],
      "name": "Anne-Laure Sellier-Leclerc"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France"
      ],
      "name": "Thomas Simon"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Hopital Trousseau la Roche-Guyon, Paris, France"
      ],
      "name": "Cyrielle Parmentier"
    },
    {
      "affiliations": [
        "Paediatric Nephrology, Hopital Necker-Enfants Malades, Paris, Île-de-France, France"
      ],
      "name": "Olivia Boyer"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, CHU de Lille, Lille, Hauts-de-France, France"
      ],
      "name": "Charlotte Samaille"
    },
    {
      "affiliations": [
        "Division of Paediatric Nephrology and Dialysis, CHU Arnaud de Villeneuve, Hospital Arnaud de Villeneuve, Montpellier, Occitanie, France"
      ],
      "name": "Marc Fila"
    },
    {
      "affiliations": [
        "Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France"
      ],
      "name": "Gwenaelle Roussey-Kesler"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Centre Hospitalier Universitaire de Nice, Nice, France"
      ],
      "name": "Marie Magnavacca"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Centre Hospitalier Régional Universitaire de Tours, Tours, France"
      ],
      "name": "Yannis Chartier"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, University Hospital Centre Rouen, Rouen, Normandy, France"
      ],
      "name": "Ferielle Louillet"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Strasbourg University Hospitals Hautepierre Hospital, Strasbourg, Grand Est, France"
      ],
      "name": "Ariane Zaloszyc"
    },
    {
      "affiliations": [
        "Paediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France"
      ],
      "name": "Isabelle Vrillon"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Robert-Debré Mother-Child University Hospital, Paris, Île-de-France, France"
      ],
      "name": "Djamel Elaribi"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Robert-Debré Mother-Child University Hospital, Paris, Île-de-France, France"
      ],
      "name": "Sabrina Bouatia"
    },
    {
      "affiliations": [
        "Clinical Investigations Centre, Assistance Publique - Hopitaux de Paris, Paris, France"
      ],
      "name": "Florentia Kaguelidou"
    },
    {
      "affiliations": [
        "Clinical Research and Epidemiology Unit, Robert-Debré Mother-Child University Hospital, Paris, Île-de-France, France"
      ],
      "name": "Sophie Guilmin-Crepon"
    },
    {
      "affiliations": [
        "Paediatric Nephrology, Robert-Debré Mother-Child University Hospital, Paris, France",
        "Paris Institute for Transplantation and Organ Regeneration, INSERM U970, Paris Cité University, Paris, France"
      ],
      "name": "Julien Hogan"
    }
  ],
  "title": "Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial",
  "uid": "185aaa1e-8e48-5e49-b8e6-a1fdb1225d17"
}