{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T08:47:05Z","timestamp":1791362825237,"version":"4.3.1"},"reference-count":28,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T00:00:00Z","timestamp":1766448000000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Programme Hospitalier de Recherche Clinique -PHRC 2020"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,11,6]]},"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\u2009mg\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      ) and in the control group, the patients receive 1 infusion of RTX (375 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ). 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study has been approved by the ethics committee (Comit\u00e9 de Protection des Personnes) of Sud M\u00e9diterrann\u00e9e 2 and authorised by the French drug regulatory agency (Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05786768\">NCT05786768<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Eudract N\u00b0<\/jats:title>\n                    <jats:p>2022-003336-59.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-111980","type":"journal-article","created":{"date-parts":[[2025,12,25]],"date-time":"2025-12-25T06:10:41Z","timestamp":1766643041000},"page":"e111980","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"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"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05786768","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02550652","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05039619","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05627557","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Claire","family":"Dossier","sequence":"first","affiliation":[{"name":"Department of Paediatric Nephrology, Robert-Debr\u00e9 Mother-Child University Hospital, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Laure","family":"Sellier-Leclerc","sequence":"additional","affiliation":[{"name":"Paediatric Nephrology, H\u00f4pital Femme M\u00e8re Enfant, Bron, Auvergne-Rh\u00f4ne-Alpes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Simon","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyrielle","family":"Parmentier","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Hopital Trousseau la Roche-Guyon, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Boyer","sequence":"additional","affiliation":[{"name":"Paediatric Nephrology, Hopital Necker-Enfants Malades, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Samaille","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, CHU de Lille, Lille, Hauts-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8857-7100","authenticated-orcid":false,"given":"Marc","family":"Fila","sequence":"additional","affiliation":[{"name":"Division of Paediatric Nephrology and Dialysis, CHU Arnaud de Villeneuve, Hospital Arnaud de Villeneuve, Montpellier, Occitanie, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwenaelle","family":"Roussey-Kesler","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Magnavacca","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Centre Hospitalier Universitaire de Nice, Nice, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannis","family":"Chartier","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Centre Hospitalier R\u00e9gional Universitaire de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferielle","family":"Louillet","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, University Hospital Centre Rouen, Rouen, Normandy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariane","family":"Zaloszyc","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Strasbourg University Hospitals Hautepierre Hospital, Strasbourg, Grand Est, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Vrillon","sequence":"additional","affiliation":[{"name":"Paediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Djamel","family":"Elaribi","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Robert-Debr\u00e9 Mother-Child University Hospital, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Bouatia","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology, Robert-Debr\u00e9 Mother-Child University Hospital, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7842-5602","authenticated-orcid":false,"given":"Florentia","family":"Kaguelidou","sequence":"additional","affiliation":[{"name":"Clinical Investigations Centre, Assistance Publique - Hopitaux de Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Guilmin-Crepon","sequence":"additional","affiliation":[{"name":"Clinical Research and Epidemiology Unit, Robert-Debr\u00e9 Mother-Child University Hospital, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4838-9417","authenticated-orcid":false,"given":"Julien","family":"Hogan","sequence":"additional","affiliation":[{"name":"Paediatric Nephrology, Robert-Debr\u00e9 Mother-Child University Hospital, Paris, France"},{"name":"Paris Institute for Transplantation and Organ Regeneration, INSERM U970, Paris Cit\u00e9 University, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,12,24]]},"reference":[{"key":"2026010703483617000_15.12.e111980.1","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2020-029249","article-title":"Incidence and Relapse of Idiopathic Nephrotic Syndrome: 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