[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steroid-sensitive-nephrotic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steroid-sensitive-nephrotic-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100504608","phase-3-rituximab-in-the-first-episode-of-paediatric-nephrotic-syndrome-100504608",false,"NCT05850546","Rituximab in the First Episode of Paediatric Nephrotic Syndrome","Efficacy and Safety of Single-dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome (nephrotic-range proteinuria and either hypoalbuminemia or edema when albumin level is not available)\n2. Estimated glomerular filtration rate (eGFR) ≥90 ml\u002Fmin per 1.73 m2 at study entry\n3. Remission at study entry\n4. the cluster of differentiation antigen 20 (CD20) positive cells in peripheral blood ≥1% total lymphocytes\n5. No immunosuppressive agents have been used within 3 months of enrolment, except for the use of corticosteroid to treat nephrotic syndrome\n6. Provision of consent by a legal representative using a document approved by the institutional review board after receiving an adequate explanation of this clinical trial. For children ages 8-18, written assent is required using age-appropriate and background-appropriate documents\n\nExclusion Criteria:\n\n1. Diagnosis of secondary NS\n2. Patients showing one of the following abnormal clinical laboratories\n3. values: leukopenia (white blood cell count ≤3.0\\*109\u002FL); moderate and severe anemia (hemoglobin \\\u003C9.0g\u002FdL); thrombocytopenia (platelet count \\\u003C100\\*1012\u002F L); positivity of autoimmunity tests (ANA, Anti DNA antibody, ANCA) or reduced C3 levels; Alanine aminotransferase or aspartate aminotransferase \\> 2.5× upper limit of normal value\n4. Presence of severe or chronic infections within 6 months before assignment: tuberculosis or in whom tuberculosis is suspected; Epstein-Barr virus or cytomegalovirus; hepatitis B or hepatitis C or hepatitis B virus carrier, human immunodeficiency virus or other active viral infections\n5. Live vaccination within last month\n6. Patients with poorly controlled hypertension\n7. Patients with severe brain, heart, liver, and other important organs, as well as blood and endocrine system diseases\n8. Presence or history of autoimmune diseases, primary immunodeficiency, or tumor\n9. Patients with a known allergy to Rituximab and its excipients\n10. Assessed to be unfit for participation by the investigators (patients highly likely to be lost to follow-up or provide inaccurate data, for example, patients with alcohol or other substance misuse disorders, and patients with psychological disorders)",true,"ALL","1 Year","18 Years",{"count":21,"type":22},138,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg\u002Fm2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.",[28],"Steroid-Sensitive Nephrotic Syndrome",[30,31,32],"Rituximab","Children","Relapse","NOT_YET_RECRUITING","2025-01-21",{"date":36,"type":37},"2025-01-22","ACTUAL",{"date":39,"type":22},"2025-03-01",{"date":41,"type":22},"2026-12-28",{"name":43,"class":44},"Children's Hospital of Fudan University","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"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":55,"type":22},88,[57,25],"PHASE2","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).",[60,28],"Steroid-Dependent Nephrotic Syndrome",[30,62,63],"Obinutuzumab","Anti-Drug Antibodies","RECRUITING","2023-11-08",{"date":67,"type":37},"2023-11-09",{"date":69,"type":37},"2023-10-18",{"date":71,"type":22},"2027-12-31",{"name":73,"class":44},"Assistance Publique - Hôpitaux de Paris",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":74},"100521150","national-registry-of-rare-kidney-diseases-100521150","NCT06065852","National Registry of Rare Kidney Diseases","National Registry of Rare Kidney Diseases (RaDaR)","RaDaR","* Kidney Rare Disease\n* Paeds and adults\n* Eligibility differs for each rare disease group\n* See: https:\u002F\u002Fukkidney.org\u002Frare-renal\u002Frecruitment",{"count":84,"type":22},35000,"30 Years","OBSERVATIONAL","The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.\n\nThe purpose of this research is to:\n\n* Develop Clinical Guidelines for specific rare kidney diseases. These are written recommendations on how to diagnose and treat a medical condition.\n* Audit treatments and outcomes. An audit makes checks to see if what should be done is being done and asks if it could be done better.\n* Further the development of future treatments.\n\nParticipants will be invited to participate on clinical trials and other studies. The registry has the capacity to feedback relevant information to patients and in conjunction with Patient Knows Best (Home - Patients Know Best), allows patients to provide information themselves, including their own reported quality of life and outcome measures.",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,28,166,167,168,169,170,171],"Adenine Phosphoribosyltransferase Deficiency","AH Amyloidosis","AHL Amyloidosis","AL Amyloidosis","Alport Syndrome","Atypical Hemolytic Uremic Syndrome","Autoimmune Distal Renal Tubular Acidosis","Autosomal Recessive Proximal Renal Tubular Acidosis","Autosomal Recessive Distal Renal Tubular Acidosis","Autosomal Dominant Polycystic Kidney Disease","Autosomal Recessive Polycystic Kidney Disease","Bartter Syndrome","BK Nephropathy","C3 Glomerulopathy With Monoclonal Gammopathy","C3 Glomerulopathy","Calciphylaxis","Crystalglobulinaemia","Crystal-storing Histiocytosis","Cystinosis","Cystinuria","Dense Deposit Disease","Dent Disease","Denys-Drash Syndrome","Dominant Hypophosphataemia With Nephrolithiasis and\u002For Osteoporosis","Drug Induced Fanconi Syndrome","Drug-Induced Hypomagnesemia","Drug-Induced Nephrogenic Diabetes Insipidus","Epilepsy, Ataxia, Sensorineural Deafness and Tubulopathy","Fabry Disease","Familial Hypomagnesemia With Hypercalciuria and Nephrocalcinosis","Familial Primary Hypomagnesemia With Hypocalcuria","Familial Primary Hypomagnesaemia With Normocalciuria","Familial Renal Glucosuria","Fanconi Renotubular Syndrome 1","Fanconi Renotubular Syndrome 2","Fanconi Renotubular Syndrome 3","Fibrillary Glomerulonephritis","Fibromuscular Dysplasia","Focal Segmental Glomerulosclerosis","Generalised Pseudohypoaldosteronism Type 1","Gitelman Syndrome","Heavy-Metal-Induced Fanconi Syndrome","Hepatocyte Nuclear Factor 1-Beta-Associated Monogenic Diabetes","Hereditary Renal Hypouricemia","Hereditary Hypophosphatemic Rickets With Hypercalciuria","Hyperuricaemic Nephropathy","IgA Nephropathy","Immunotactoid Glomerulonephritis With Organised Microtubular Mononoclonal Immunoglobulin Deposits","Inherited Renal Cancer Syndromes","Intracapillary Monoclonal IgM Without Cryoglobulin","Intraglomerular\u002FCapillary Lymphoma\u002FLeukaemia","Isolated Autosomal Dominant Hypomagnesaemia Glaudemans Type","Liddle Syndrome","Light Chain Cast Nephropathy","Light Chain Proximal Tubulopathy Without Crystals","Light Chain Proximal Tubulopathy With Crystals","Lowe Syndrome","Membranous Nephropathy","Membranoproliferative Glomerulonephritis","Medullary Cystic Kidney Disease","Minimal Change Nephropathy","Mitochondrial Disease Of The Kidney","Monoclonal Immunoglobulin Deposition Disease","Nail Patella Syndrome","Nephrogenic Diabetes Insipidus","Nephrogenic Syndrome of Inappropriate Antidiuresis","Nephronophthisis","Primary Hypomagnesemia With Secondary Hypocalcemia","Primary Hyperoxaluria","Proliferative Glomerulonephritis With Monoclonal IgG Deposits","Proximal Tubulopathy Without Crystals","Pseudohypoaldosteronism Type 1, 2A-2E","Pure Red Cell Aplasia","Retroperitoneal Fibrosis","Sickle Cell Nephropathy","Shiga Toxin Associated Haemolytic Uraemic Syndrome","Steroid Resistant Nephrotic Syndrome","Thin Basement Membrane Nephropathy","Thrombotic Microangiopathy With Monoclonal Gammopathy","Type 1 Cryoglobulinaemic Glomerulonephritis","Tuberous Sclerosis","Unclassified Monoclonal Gammopathy Of Renal Significance","Vasculitis","2023-09-26",{"date":174,"type":37},"2023-10-04",{"date":176,"type":37},"2009-11-06",{"date":178,"type":22},"2039-12-31",{"name":180,"class":44},"UK Kidney Association"]