[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576988":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":10,"responsibleParty":31,"collaborators":33,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":10,"maxAge":56,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":72,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":10},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Treatment-Naive Idiopathic Nephrotic Syndrome (INS) Patients",null,"This cohort comprises 110 children diagnosed with idiopathic nephrotic syndrome (INS) who are treatment-naive at enrollment. The participants will receive a standard induction therapy with prednisone or prednisolone and will be followed for 12 months. During this period, blood and urine samples will be collected at various points (enrollment, 6 weeks, 6 months, and 12 months) and in cases of relapse. The goal is to monitor disease progression and classify patients based on their response to therapy, specifically identifying subtypes such as steroid-resistant, steroid-dependent, and infrequent relapsing nephrotic syndrome .",{"label":13,"type":10,"description":14,"interventionNames":10},"Healthy Pediatric Control Group","This cohort consists of 40 age-matched children without nephrotic syndrome, selected from individuals undergoing minor urological surgical procedures. These participants will provide baseline control samples (blood and urine) for comparison with the INS patients' samples. This group allows researchers to identify molecular characteristics unique to INS by contrasting them with data from healthy children .",{"label":16,"type":10,"description":17,"interventionNames":10},"Prevalent Idiopathic Nephrotic Syndrome (INS) Patients","This group includes 200 INS patients who have previously received treatment and are part of the larger validation phase. This cohort will be used to confirm the biomarkers and molecular profiles identified in the main cohort. The aim is to generalize findings and ensure that identified biomarkers are consistent across a broader population. Samples will be collected during relapse and remission, aligning with the study's focus on validating predictive biomarkers of disease course and therapeutic response .",[19],{"name":20,"affiliation":5,"role":21},"Giovanni Montini, Doctor of Medicine","PRINCIPAL_INVESTIGATOR",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Federica Lugani, Doctor of Medicine","CONTACT","+39 02 5503 3434","federica.lugani@policlinico.mi.it",{"name":29,"role":25,"phone":26,"phoneExt":10,"email":30},"William Morello, Doctor of Medicine","william.morello@policlinico.mi.it",{"type":32,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[34,37,39,41,43,45],{"name":35,"class":36},"Fondazione La Nuova Speranza ONLUS","UNKNOWN",{"name":38,"class":36},"ASSOCIAZIONE SINDROME NEFROSICA ITALIA",{"name":40,"class":36},"Nephie e.V.",{"name":42,"class":36},"NephCEurope",{"name":44,"class":36},"European Joint Programme on Rare Diseases (EJP RD JTC 2023)",{"name":46,"class":36},"ERKNet","100576988","biomarkers-and-outcome-predictors-of-pediatric-nephrotic-syndrome-a-genetic-transcriptomic-and-secretome-multiomics-study-100576988",false,"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,"ALL","18 Years",{"count":58,"type":59},350,"ESTIMATED","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.",[64,65,66,67,68,69,70,71],"Nephrotic Syndrome Steroid-Dependent","Nephrotic Syndrome Steroid-Resistant","Nephrotic Syndrome in Children","Glomerulonephritis","Proteinuria","Hypoalbuminemia","Kidney Diseases","Chronic Kidney Disease",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"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":91,"type":92},"2025-01-30","ACTUAL",{"date":94,"type":59},"2025-02-15",{"date":96,"type":59},"2028-06-01",{"name":5,"class":6}]