[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steroid-dependent-nephrotic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steroid-dependent-nephrotic-syndrome":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100593207","early-phase-1-study-on-the-efficacy-and-safety-of-fecal-microbiota-transplantation-in-the-treatment-of-steroid---dependent-steroid-resistant-nephrotic-syndrome-in-children-100593207",false,"NCT07003438","Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Steroid - Dependent \u002FSteroid-resistant Nephrotic Syndrome in Children","Inclusion Criteria:\n\n* Age 2-18 years, steroid-dependent\u002Fsteroid-resistant nephrotic syndrome, regardless of gender, with SDNS at steroid-dependent doses less than 0.5 mg\u002Fkg.d\n\nExclusion Criteria:\n\n* Those with concurrent infections or diseases of other organ systems, and those with abnormal renal function.","ALL","2 Years","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The objective of this clinical trial was to understand whether FMT is effective in treating steroid-dependent\u002Fsteroid-resistant nephrotic syndrome in children. It will also learn about the safety of FMT. The main question it was designed to answer was: Did FMT reduce participants '24-hour urine protein content? What medical problems did participants experience while using FMT? The researchers will compare FMT treatment with and without FMT on top of conventional treatment to see if FMT is effective in treating steroid-dependent\u002Fsteroid-resistant nephrotic syndrome in children. Participants will receive 2 FMT treatments, 1 endoscopic injection under anesthesia, 1 oral fecal bacteria transplantation capsule intake, and follow-up visits (weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48) every 4 weeks from the beginning of medication to our renal specialist clinic for drug efficacy evaluation and safety testing. Blood and fecal samples were collected to determine the effects of fecal bacterial transplantation on intestinal flora, fecal metabolomics, and intestinal mucosal permeability.",[26,27],"Steroid-Resistant Nephrotic Syndrome","Steroid-Dependent Nephrotic Syndrome","NOT_YET_RECRUITING","2025-06-03",{"date":31,"type":32},"2025-06-04","ACTUAL",{"date":34,"type":20},"2025-06-01",{"date":36,"type":20},"2028-04-01",{"name":38,"class":39},"Zhang Ting","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100499708","phase-2-efficacy-and-safety-of-obinutuzumab-versus-rituximab-in-childhood-steroid-dependant-and-frequent-relapsing-nephrotic-syndrome-100499708","NCT05786768","Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome","Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study","OBIRINS","Inclusion Criteria:\n\n* Age between 3 and 18 years\n* Steroid dependant Nephrotic Syndrome defined as:\n\n  * 2 or more relapses during steroids or within 2 weeks following discontinuation.\n  * 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal\n\nOR Frequent Relapsing Nephrotic Syndrome defined as:\n\n* 2 or more relapses within 6 months following first remission\n* 3 or more relapses within any 12-month period\n\n  * Last relapse within 3 months prior to inclusion\n  * In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization\n  * Vaccination schedule in accordance with the current recommendations in France\n  * Informed consent from parents\n\nExclusion Criteria:\n\n* Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)\n* Primary or secondary steroid resistance nephrotic syndrome\n* Prior treatment with Rituximab within 6 months\n* Prior treatment with obinutuzumab at any time\n* CD20+ B-cell count \\\u003C 2.5%\n* Patient with neutrophils \\\u003C 1.5 G\u002FL and\u002For platelets \\\u003C 75 G\u002FL\n* GFR \\\u003C 80 ml\u002Fmin\u002F1.73m2\n* Weight \\\u003C16kg\n* History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP\n* History of malignancy- Uncontrolled infection (viral, bacterial and fungal)\n* Vaccination with a live vaccine within 4 weeks prior to assignment\u002Frandomization\n* Known hyperprolinemia\n* Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients\n* Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab\u002FRituximab at the beginning of the study)\n* Patient without medical insurance coverage (beneficiary or legal)","3 Years",{"count":50,"type":20},88,[52,53],"PHASE2","PHASE3","B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD\u002FFRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).",[27,56],"Steroid-Sensitive Nephrotic Syndrome",[58,59,60],"Rituximab","Obinutuzumab","Anti-Drug Antibodies","RECRUITING","2023-11-08",{"date":64,"type":32},"2023-11-09",{"date":66,"type":32},"2023-10-18",{"date":68,"type":20},"2027-12-31",{"name":70,"class":39},"Assistance Publique - Hôpitaux de Paris",1,"Steroid Dependent Nephrotic Syndrome"]