[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nephrotic-syndrome-steroid-dependent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nephrotic-syndrome-steroid-dependent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100599952","phase-2-dupilumab-therapy-in-nephrotic-syndrome-in-children-100599952",false,"NCT07091175","Dupilumab Therapy in Nephrotic Syndrome in Children","Singapore-Malaysian Renal Trials - Nephrotic Syndrome (SMART-NS): Dupilumab Maintenance Therapy for Steroid-dependent and Frequently Relapsing Nephrotic Syndrome","SMART-NS","Inclusion Criteria:\n\n1. Age between 6 years old and 18 years old at the point of recruitment with idiopathic nephrotic syndrome with disease onset between 1-18 years old\n2. Steroid-dependent disease or frequently relapsing disease prior to commencement of maintenance immunosuppression\n3. On oral prednisolone +\u002F- mycophenolate or levamisole only as maintenance therapy for 6 months or more, and with inadequate disease control or steroid toxicity on therapy\n4. Nephrotic relapse or partial relapse (clinical or biochemical) within the last 1 year either unprovoked or during prednisolone wean, and which responded to increase in steroids\n5. In complete remission at the time of recruitment\n6. Competent with, and compliant to, daily urine protein monitoring with Albustix\n\nExclusion Criteria:\n\n1. Pre-existing ophthalmological conditions except refractive errors, squint or mild cataract\n2. Current symptoms of helminth infection or travel to endemic areas, unless helminth infection is excluded\n3. eGFR (by Bedside Schwartz equation) \\\u003C60 ml\u002Fmin\u002F1.73m2\n4. Received Rituximab or other B-cell depleting agents within the last 1 year\n5. Biopsy proven focal segmental glomerulosclerosis\n6. Known ongoing infection including HIV, Hepatitis B, Hepatitis C or tuberculosis, otherwise immunosuppressed or with frequent infections\n7. Known or suspected non-compliance to medication or follow-up\n8. Pregnancy or intention to become pregnant\n9. Major systemic conditions, i.e. ASA Physical Status III-IV.\n10. Known hypersensitivity to dupilumab or any of its excipients","ALL","6 Years","18 Years",{"count":21,"type":22},66,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if dupilumab works to treat severe nephrotic syndrome in children. It will also learn about the safety of dupilumab.\n\nThe main questions it aims to answer are:\n\n* Does dupilumab reduce the time to relapse of nephrotic syndrome?\n* What medical problems do participants have when taking dupilumab?\n\nResearchers will compare dupilumab to a placebo (a look-alike substance that contains no drug) to see if dupilumab works to treat severe nephrotic syndrome.\n\nParticipants will:\n\n* Receive an injection of dupilumab or placebo (just under the skin) every 2 weeks (if ≥30kg) or every 4 weeks (if \\\u003C30kg) for 24 weeks (6 months)\n* Wean down their prednisolone dose after starting the injections of dupilumab or placebo\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a nephrotic diary to record down the urine dipstick result each day, together with the dose of prednisolone taken\n\nIf protein returns in participant's urine, they will have completed the study at that point. However, if the participant is found to have received the placebo, they will be offered to receive dupilumab for up to 24 weeks.",[28,29],"Nephrotic Syndrome in Children","Nephrotic Syndrome Steroid-Dependent",[31,32,33,34,35],"Dupilumab","Steroid sensitive nephrotic syndrome","Steroid dependent nephrotic syndrome","Frequently relapsing nephrotic syndrome","Paediatric","RECRUITING","2025-11-27",{"date":39,"type":40},"2025-12-05","ACTUAL",{"date":37,"type":40},{"date":43,"type":22},"2028-02-28",{"name":45,"class":46},"National University Hospital, Singapore","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":4,"maxAge":19,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100576988","biomarkers-and-outcome-predictors-of-pediatric-nephrotic-syndrome-a-genetic-transcriptomic-and-secretome-multiomics-study-100576988","NCT06792448","Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study","PRECISE","Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic nephrotic syndrome (INS) with nephrotic range proteinuria (uPr\u002FuCr ratio \\> 2 mg\u002Fmg).\n* Hypoalbuminemia with serum albumin \\\u003C 3.0 g\u002FdL.\n* Presence of edema.\n* No prior treatment for idiopathic nephrotic syndrome.\n* Age between 1 and 18 years at the time of enrollment.\n* igned informed consent by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Diagnosis of congenital or infantile nephrotic syndrome (age \\\u003C 1 year).\n* Diagnosis of secondary nephrotic syndrome.\n* Presence of glomerulonephritis, autoimmune diseases, or vasculitis.\n* Lack of signed informed consent by a parent or legal guardian.\n* Previous treatment with prednisone or prednisolone for nephrotic syndrome.",true,{"count":56,"type":22},350,"1 Year","OBSERVATIONAL","Idiopathic Nephrotic Syndrome is a rare disease of the kidneys, which typically affects children. For most affected children there is the need of a prolonged treatment with drugs reducing the activity of the immune system, also resulting in many side effects. Those patients, who do not respond to treatment, are at risk of kidney damage and of dialysis or kidney transplantation. It is currently impossible to predict the response to treatment, leading to unnecessary therapies with side effects as well as unclear prognosis in the affected children. The response of the idiopathic nephrotic syndrome to medications acting on the immune system explains its important role in the occurrence of the disease.\n\nWith this study we aim to obtain predictors of the response to treatment right at the beginning of the disease, to adapt the therapy avoiding needless side effects. This will be done evaluating the blood and urine of affected children using state of the art molecular characterisation. We will evaluate the genetic predisposition, the cell trait changes and the presence of molecules in blood and urine that may affect the interaction between the immune system and the kidneys. We expect that the findings will improve treatment of children with idiopathic nephrotic syndrome and reduce the number of children suffering from unnecessary drugs related side effects.",[29,61,28,62,63,64,65,66],"Nephrotic Syndrome Steroid-Resistant","Glomerulonephritis","Proteinuria","Hypoalbuminemia","Kidney Diseases","Chronic Kidney Disease",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"Pediatric nephrotic syndrome","Idiopathic nephrotic syndrome","Steroid-resistant nephrotic syndrome","Steroid-sensitive nephrotic syndrome","Biomarkers discovery","Genetic risk factors","Epigenetic analysis","Adaptive immune system profiling","Liquid biopsy","Serum and urine proteomics","Multiomics approach","Personalized treatment","Disease progression prediction","Molecular characterization","Pediatric kidney disease","NOT_YET_RECRUITING","2025-01-28",{"date":86,"type":40},"2025-01-30",{"date":88,"type":22},"2025-02-15",{"date":90,"type":22},"2028-06-01",{"name":92,"class":46},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"]