{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T15:49:08Z","timestamp":1782488948658,"version":"3.54.5"},"reference-count":33,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T00:00:00Z","timestamp":1600819200000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Programme Hospitalier de Recherche Clinique - PHRC 2016","award":["PHRCN-16-0547"],"award-info":[{"award-number":["PHRCN-16-0547"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,7,23]]},"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking. Given the substantial impact of SDNS\/FRNS on quality of life, strategies aiming to provide long-term remission while minimising treatment side effects are needed. Several studies confirm that rituximab is effective in preventing early relapses in SDNS\/FRNS; however, the long-term relapse rate remains high (~70% at 2 years). This trial will assess the association of intravenous immunoglobulins (IVIgs) to rituximab in patients with SDNS\/FRNS and inform clinicians on whether IVIg\u2019s immunomodulatory properties can alter the course of the disease and reduce the use of immunosuppressive drugs and their side effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We conduct an open-label multicentre, randomised, parallel group in a 1:1 ratio, controlled, superiority trial to assess the safety and efficacy of a single infusion of rituximab followed by IVIg compared with rituximab alone in childhood-onset FRNS\/SDNS. The primary outcome is the occurrence of first relapse within 24 months. Patients are allocated to receive either rituximab alone (375 mg\/m\u00b2) or rituximab followed by IVIg, which includes an initial Ig dose of 2\u2009g\/kg, followed by 1.5\u2009g\/kg injections once a month for the following 5\u2009months (maximum dose: 100\u2009g).<\/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 Ouest I 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\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT03560011\">NCT03560011<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-037306","type":"journal-article","created":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T17:16:08Z","timestamp":1600881368000},"page":"e037306","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct03560011","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4838-9417","authenticated-orcid":false,"given":"Julien","family":"Hogan","sequence":"first","affiliation":[{"name":"Department of Pediatric Nephrology, Robert Debr\u00e9 Hospital, APHP, Paris, France"},{"name":"Department of Surgery, Emory University, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aubriana","family":"Perez","sequence":"additional","affiliation":[{"name":"Department of Surgery, Emory University, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Laure","family":"Sellier-Leclerc","sequence":"additional","affiliation":[{"name":"Department of Pediatric Nephrology, H\u00f4pital Femme M\u00e8re Enfant, Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Vrillon","sequence":"additional","affiliation":[{"name":"Department of Pediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francoise","family":"Broux","sequence":"additional","affiliation":[{"name":"Department of Pediatric Nephrology, University Hospital Centre Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Nobili","sequence":"additional","affiliation":[{"name":"Department of Pediatric Nephrology, University Hospital Centre Besancon, Besancon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerome","family":"Harambat","sequence":"additional","affiliation":[{"name":"Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Bordeaux Groupe hospitalier Pellegrin, Bordeaux, 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