[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nephrotic-syndrome-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nephrotic-syndrome-in-children":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,55,84,103,127,159,187,231,257,285,310,333],{"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":37,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100406380","neptune-match-study-100406380",false,"NCT04571658","NEPTUNE Match Study","Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)","NEPTUNE Match","Inclusion Criteria:\n\n1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study\n2. Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).\n\n   Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.\n3. Regular nephrology healthcare provided at a NEPTUNE study site.\n4. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match\n\nExclusion Criteria:\n\nCurrently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.\n\nExclusion Criteria:\n\n1\\. Non-English or non-Spanish speaking","ALL","1 Year","80 Years",{"count":21,"type":22},375,"ESTIMATED","INTERVENTIONAL",[25],"NA","NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.",[28,29,30,31,32,33,34,35,36],"Nephrotic Syndrome in Children","Focal Segmental Glomerulosclerosis","Minimal Change Disease","Minimal Change Nephrotic Syndrome","Membranous Nephropathy","FSGS","MCD","MCD - Minimal Change Disease","Alport Syndrome",[38,39,40,41],"Nephrotic Syndrome","NEPTUNE","Match","Clinical Trial Match","RECRUITING","2026-06-08",{"date":45,"type":46},"2026-06-10","ACTUAL",{"date":48,"type":46},"2022-05-02",{"date":50,"type":22},"2029-12-30",{"name":52,"class":53},"University of Michigan","OTHER",16,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100484123","a-pilot-trial-of-tavns-for-srns-in-children-kidney-vns-100484123","NCT05583942","A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)","A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Steroid Resistant Nephrotic Syndrome in Children","kidNEY-VNS","Inclusion Criteria:\n\n* Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone\u002Fprednisone at standard dose1\n* Age 3-17 years\n* eGFR ≥30 ml\u002Fmin\u002F1.73 m2 (by modified Schwartz formula)\n* MCD or FSGS diagnosis (per biopsy)\n* Urine protein:creatinine (UPC) greater than 1.0\n* Stable immunosuppression and ACE inhibitor\u002Fangiotensin receptor blocker treatment regimen for at least three months\n* Evidence of B cell repletion for those exposed to rituximab\n* Informed consent from the parent or guardian and assent from a minor of ≥ 7 years\n* Ability to comply with the study protocol, in the investigator's judgment\n\nExclusion Criteria:\n\n* Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)\n* Steroid sensitive nephrotic syndrome\n* History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \\[podocin\\], NPHS1 \\[nephrin\\], PLCE1, WT1, or other known genetic cause)\n* Any known inflammatory condition\n* History of cardiac disease (arrhythmias, structural\u002Ffunctional abnormalities)\n* Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)\n* Chronic rash or skin breakdown of the left ear at the cymba concha\n* Pregnancy","3 Years","17 Years",{"count":66,"type":22},10,[25],"Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.",[28,30,29],[71,72,73],"vagus nerve stimulation","pediatric","nephrology","2026-04-14",{"date":76,"type":46},"2026-04-17",{"date":78,"type":46},"2022-09-19",{"date":80,"type":22},"2027-08-01",{"name":82,"class":53},"Northwell Health",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":61,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":102,"locationsCount":83},"100484439","tavns-for-frns-in-children-100484439","NCT05588063","taVNS for FRNS in Children","A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children","Inclusion Criteria:\n\n* FRNS\n* Age 3-17 years\n* Glomerular filtration rate (eGFR) ≥30 ml\u002Fmin\u002F1.73 m2\n* Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)\n* Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy)\n* In remission at time of enrollment (remission defined as UPC \\\u003C0.2 or negative dipstick for 3 consecutive days)\n* Informed consent from the parent or guardian and assent from a minor of ≥ 7. years\n\nExclusion Criteria:\n\n* Secondary forms of nephrotic syndrome\n* SRNS\n* Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)\n* Exposure to steroids within 14 days of enrollment\n* Receiving any standing immunosuppression (previous exposure \\> 2 months allowed and\u002For B cell repletion)\n* Any known inflammatory condition (e.g. systemic lupus erythematosis)\n* History of cardiac disease (arrhythmias, structural\u002Ffunctional abnormalities)\n* Implantable electronic devices\n* Pregnancy\n* Participants\u002Fguardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures",{"count":92,"type":22},30,[25],"Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated non invasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.",[28,30,29],[71,72,73],{"date":98,"type":46},"2026-04-15",{"date":100,"type":46},"2023-01-05",{"date":80,"type":22},{"name":82,"class":53},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100599655","phase-2-a-study-of-anti-cd38-monoclonal-antibody-sg301-subcutaneous-injection-in-children-with-nephrotic-syndrome-with-frequent-relapses-or-steroid-dependence-100599655","NCT07087314","A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence","A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome","Inclusion Criteria:\n\n1. Aged 6 - 18 years.\n2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).\n3. Normal renal function: eGFR≥90 ml\u002Fmin\u002F1.73m².\n4. After steroid treatment, morning urine protein\\\u003C1 + or urine protein\u002Fcreatinine\\\u003C0.2 g\u002Fg (\\\u003C20 mg\u002Fmmol) for ≥3 consecutive days.\n5. Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\\>80 g\u002FL; platelets\\>75×10⁹\u002FL; neutrophils\\>1.5×10⁹\u002FL.\n6. Prothrombin time\u002FINR≤1.5×ULN, unless due to anticoagulation.\n7. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.\n\nExclusion Criteria:\n\n1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.\n2. Alanine aminotransferase \\>2×ULN or total bilirubin\\>2×ULN with a sustained increase for 2 weeks.\n3. HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.\n4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids\u002F immunosuppressants.\n5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics\u002Fantivirals.\n6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).\n7. Other autoimmune diseases, primary immunodeficiency, or malignancy.\n8. Prior anti - cluster of differentiation 38 (CD38) treatment.\n9. Live\u002Fattenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.","6 Years","18 Years",{"count":92,"type":22},[114],"PHASE2","This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.",[28],"2026-02-26",{"date":119,"type":46},"2026-02-27",{"date":121,"type":46},"2025-08-25",{"date":123,"type":22},"2029-07-09",{"name":125,"class":53},"Mao Jianhua",1,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":148,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":126},"100478094","interview-study-of-adult-and-child-patients-and-parents-of-children-with-swelling-due-to-nephrotic-syndrome-100478094","NCT05505500","Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.","Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome","Prepare-NS","Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:\n\nInclusion Criteria:\n\n1. Parents\u002Fguardians must be able to read and understand English;\n2. Parents\u002Fguardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;\n3. The child must have a current NS-associated edema\n4. The child must have native kidney function\n5. Parents\u002Fguardians must provide informed consent.\n\nExclusion Criteria:\n\n1\\. Index case with dialysis dependence throughout the 3-month pre-enrollment period\n\nCriteria for the Patient Reported Outcomes (PRO) cohort of the study:\n\nInclusion Criteria:\n\n1. ≥8 years of age\n2. Able to read and understand English\n3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.\n\n   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied\n4. Current NS-associated edema\n5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \\> 25 ml\u002Fmin\u002F1.73m2\n6. Informed Consent: For patients ≥8 to \\\u003C18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.\n\nExclusion Criteria:\n\n1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period\n2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS","2 Years",{"count":137,"type":22},150,"OBSERVATIONAL","Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.\n\nPlease consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.",[141,142,143,32,30,31,144,38,145,146,28,147,33],"Fluid Overload","Glomerulosclerosis, Focal Segmental","Edema","IgM Nephropathy","Glomerular Disease","Nephrotic Syndrome, Minimal Change","Nephrotic Syndrome With Edema (Diagnosis)",[38,149,150,141,143,33,30,32,144],"Child","Adult","2025-12-15",{"date":153,"type":46},"2025-12-22",{"date":155,"type":46},"2022-04-18",{"date":157,"type":22},"2026-04-30",{"name":52,"class":53},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":111,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":83},"100599952","phase-2-dupilumab-therapy-in-nephrotic-syndrome-in-children-100599952","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",{"count":168,"type":22},66,[114],"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.",[28,172],"Nephrotic Syndrome Steroid-Dependent",[174,175,176,177,178],"Dupilumab","Steroid sensitive nephrotic syndrome","Steroid dependent nephrotic syndrome","Frequently relapsing nephrotic syndrome","Paediatric","2025-11-27",{"date":181,"type":46},"2025-12-05",{"date":179,"type":46},{"date":184,"type":22},"2028-02-28",{"name":186,"class":53},"National University Hospital, Singapore",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":194,"sex":17,"minAge":4,"maxAge":111,"enrollmentInfo":195,"targetDuration":18,"studyType":138,"phases":4,"briefSummary":197,"conditions":198,"keywords":205,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"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":196,"type":22},350,"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.",[172,199,28,200,201,202,203,204],"Nephrotic Syndrome Steroid-Resistant","Glomerulonephritis","Proteinuria","Hypoalbuminemia","Kidney Diseases","Chronic Kidney Disease",[206,207,208,209,210,211,212,213,214,215,216,217,218,219,220],"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":224,"type":46},"2025-01-30",{"date":226,"type":22},"2025-02-15",{"date":228,"type":22},"2028-06-01",{"name":230,"class":53},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":111,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":126},"100525720","phase-3-study-of-the-telitacicept-in-pediatric-patients-with-frequently-relapsing-or-steroid-dependent-nephrotic-syndrome-100525720","NCT06125405","Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome","STERN","Inclusion Criteria:\n\n* Sensitive but frequent relapses or steroids dependence nephrotic syndrome\n* Age: 2 to 18 years old\n* Normal renal function: estimated glomerular filtration rate ≥90ml\u002F min\u002F1.73m2\n* Morning urine protein \\\u003C1+ or urine protein-creatinine ratio \\\u003C0.2g\u002Fg (\\\u003C20 mg\u002F mmol) for 3 consecutive days and above when in enroll\n* No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment\n\nExclusion Criteria:\n\n* Family history of nephrotic syndrome, chronic glomerulonephritis or uremia\n* Leukopenia (White Blood Cells ≤ 3.0 \\* 10\\^9 \u002F L)\n* Moderate to severe anemia (hemoglobin \\\u003C9.0 g\u002FdL)\n* Thrombocytopenia (platelet count \\\u003C100\\*10\\^12\u002FL)\n* Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or \u002F and Hepatitis B virus e antigen or \u002F and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)\n* There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness\n* Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)\n* Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney\n* Those who with other autoimmune diseases or primary immunodeficiencies or tumors\n* Those who have participated in other clinical trials within three months prior to the enrollment\n* Those who was not suitable for participating this study judged by investigator",{"count":239,"type":22},20,[241],"PHASE3","The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.",[28,244],"Telitacicept",[244,246,247],"Frequently Relapsing Nephrotic Syndrome","Steroid Dependent Nephrotic Syndrome","2024-08-20",{"date":250,"type":46},"2024-08-21",{"date":252,"type":46},"2023-11-28",{"date":254,"type":22},"2027-10-24",{"name":256,"class":53},"The Children's Hospital of Zhejiang University School of Medicine",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":264,"maxAge":111,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100498639","phase-4-the-efficacy-and-safety-of-prednisone-combined-with-huaiqihuang-granule-for-primary-nephrotic-syndrome-in-children-100498639","NCT05772871","The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children","Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study","Inclusion Criteria:\n\n* Age from 1.5 to 18 years;\n* According to the Evidence-based Guideline for Diagnosis and Treatment of Hormone-sensitive, Relapsed\u002Fdependent Nephrotic Syndrome in Children (2016), children diagnosed with PNS;\n* At enrollment, estimated glomerular filtration rate (eGFR)≥90ml\u002Fmin\u002F1.73m2；\n* At enrollment, serum albumin level below 30g\u002FL, and morning urine protein is 4+ or urinary albumin\u002Fcreatinine ratio (ACR)≥2.0g\u002Fg;\n* Volunteered to participate in this study and signed informed consent. For children less than 8 years, legal guardians need to sign the informed consent.\n\nExclusion Criteria:\n\n* Children who were diagnosed as steroid-resistant NS;\n* Patients who received Prednisone, other corticosteroids (like Prednisolone, Methylprednisolone), or immunosuppressants (Tacrolimus, Mycophenolate Mofetil, Cyclosporine A, Rituximab, Cyclophosphamide) within 3 months before enrollment;\n* Secondary NS caused by lupus nephritis, hepatitis B associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;\n* With combined diseases of autoimmune disorder or primary immunodeficiency or malignancy;\n* With combined diseases of the cardiovascular, liver, hematopoietic system, mental disorders, and other serious diseases;\n* With serious infectious diseases (like tuberculosis) in the past or at present;\n* With combined diseases of Human immunodeficiency virus (HIV), hepatitis B and \u002For C virus (HBV, HCV), and other active virus infections;\n* History of diabetes;\n* Abnormal liver function: alanine aminotransferase and aspartate aminotransferase levels exceed twice the upper limit of the normal range;\n* Participation in other ongoing clinical trials;\n* Other reasons that the researcher considers unsuitable to participate in this study.","18 Months",{"count":266,"type":22},402,[268],"PHASE4","This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of primary nephrotic syndrome (PNS) in children.",[28],[272,273,274],"Huaiqihuang granule","Children","Nephrotic syndrome","2024-06-20",{"date":277,"type":46},"2024-06-21",{"date":279,"type":46},"2023-04-26",{"date":281,"type":22},"2025-10-30",{"name":283,"class":53},"Jianhua Zhou",26,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":126},"100504106","phase-2-efficacy-and-safety-of-rituximab-versus-mycophenolate-mofetil-in-children-with-steroid-dependent-nephrotic-syndrome-100504106","NCT05843968","Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome","Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* Children with a definite diagnosis of SDNS are included in the study during relapse treatment.\n* Age 3-16 years.\n* Steroid dependent dose≤0.3mg\u002Fkg\u002Fday.\n* Cumulative steroid use for ≥6 months.\n* Ability to swallow tablet.\n* Guardians understand the characteristics and personal consequences of clinical trial.\n* Guardians willing to give informed written consent.\n\nExclusion Criteria:\n\n* Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.\n* Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.\n* Diagnosis of hereditary nephrotic syndrome.\n* Full dose of prednisone (2mg\u002Fkg\u002Fday, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.\n* Estimated glomerular filtration rate (eGFR) \\\u003C90mL\u002Fmin per 1.73m\\^2 at study entry.\n* Those who with a known allergy to Mycophenolate Mofetil and their excipients or to Rituximab and its excipients.\n* Those who refuse to participate in the trial.\n* Those who participate other clinical trials.\n* Those who with positive HBV serological markers (HBsAg or\u002Fand HBeAg or\u002Fand HBcAb), HCV positive patients or patients with abnormal liver function (ALT,AST,or bilirubin\\>2 or more times the upper limit of the normal range and persistently elevated for 2 weeks).\n* Severe leukopenia (white blood cells\\\u003C3.0×10\\^9), severe anemia (hemoglobin\\\u003C90g\u002Fl), and thrombocytopenia (platelets\\\u003C100×10\\^9) at study entry.\n* History of pancreatitis or definite gastrointestinal ulcers and\u002For gastrointestinal bleeding within 6 months.\n* Those who with congenital or acquired immune deficiency, or with active tuberculosis, active CMV and other infections.\n* Those who with other serious physical or mental illnesses.\n* History of malignant tumor within 5 years.\n* Those who with congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases.\n* Those who with serious infections requiring intravenous antibiotics.","16 Years",{"count":294,"type":22},46,[114],"The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).",[28],[38,299,300],"Rituximab","Mycophenolate Mofetil","2024-04-18",{"date":303,"type":46},"2024-04-19",{"date":305,"type":46},"2023-01-29",{"date":307,"type":22},"2026-07-01",{"name":309,"class":53},"Children's Hospital of Chongqing Medical University",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100522220","phase-3-study-of-adrenocorticotropic-hormone-on-children-with-frequent-relapse-or-steroid-dependent-nephrotic-syndrome-a-prospective-multicenter-randomizedopen-label-clinical-trial-100522220","NCT06079788","Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.","Inclusion Criteria:\n\n1. Age 2-14 years old;\n2. Sensitive but frequent relapses or steroids dependence nephrotic syndrome\n3. No severe hormonal side effects and\u002For low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose \\\u003C 0.5mg\u002Fkg\u002Fday or equivalent alternate-day dose)\n4. Normal renal function: eGFR≥90ml\u002Fmin\u002F1.73m2;\n5. Morning urine protein \\\u003C1+ or urine protein-creatinine ratio \\\u003C0.2g\u002Fg (\\\u003C20 mg\u002Fmmol) for 3 consecutive days and above when in enroll;\n6. Prednisone dose was 1.5-2 mg\u002Fkg per day before admission;\n7. No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.\n\nExclusion Criteria:\n\n1. Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;\n2. Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;\n3. Recurrent or persistent hypertension;\n4. Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;\n5. Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;\n6. Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions;\n7. Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;\n8. Patients with serious autoimmune diseases or tumors;\n9. Use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months;\n10. Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects\n11. History of organ transplantation (excluding corneal and hair transplantation);\n12. Patients who had participated in other clinical trials within three months prior to enrollment;\n13. Any patient whom the investigator determines is not suitable for inclusion in the trial.","14 Years",{"count":318,"type":22},140,[241],"Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse\u002Fsteroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, multicenter, randomized，open-label clinical trial, evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormone（ACTH） to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.",[28],[38,246,247,323],"Adrenocorticotropic Hormone","2023-10-08",{"date":326,"type":46},"2023-10-12",{"date":328,"type":22},"2023-11-01",{"date":330,"type":22},"2026-12-31",{"name":125,"class":53},8,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":64,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":126},"100495714","phase-3-study-of-rituximab-monotherapy-on-children-with-new-onset-nephrotic-syndrome-a-randomized-controlled-trial-100495714","NCT05734794","Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial","Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial","STORM","Inclusion Criteria:\n\n1. New-onset idiopathic nephrotic syndrome\n2. Glomerular filtration rate (eGFR) ≥90 ml\u002Fmin per 1.73 m2 at study entry.\n\nExclusion Criteria:\n\n1. Glomerular hematuria: Urine red blood cell counts≥ 10\u002Fhigh power field(HP), ≥ 3 times within 2 weeks;\n2. Continuous hypocomplementaemia(\\\u003C 0.9g\u002FL) ;\n3. Repeated or persistent Hypertension(systolic and\u002For diastolic blood pressures measured greater than the 95th percent of blood pressure in children matching sex, age and height ≥3 different time points)\n4. Diagnosis of secondary NS, such as secondary to Systemic Lupus Erythematosus, Immunoglobulin A Vasculitis(IgAV), diabetes, Hepatitis B virus(HBV) infection, etc.\n5. Complicated with other kidney diseases, such as multiple renal cysts, ANCA vasculitis, urinary system abnormalities, etc;\n6. With a family history of nephrotic syndrome, chronic glomerulonephritis, uremia, or other kidney diseases;\n7. Other monogenic genetic diseases known as the effect the condition of nephrotic syndromes, such as Wilms' tumor 1(WT1), NPHS2, LAMB2, PLCE1, etc.\n8. Congenital or acquired immunodeficiency, or patients with active tuberculosis, active Epstein-Barr virus and cytomegalovirus(CMV), acute hepatitis B, hepatitis C, HIV infection, deep fungal infection or other active infections.\n9. Laboratory indicators were abnormal, such as moderate or severe neutropenia(≤1000\u002FμL)， moderate or severe anemia(hemoglobin\\\u003C9.0g\u002FdL), Thrombocytopenia (platelet count\\\u003C100\\* 10\\^12\u002FL) or with abnormal hepatic function (Alaninetransaminase(ALT), aspartate Aminotransferase(AST) or bilirubin \\>2.5\\*upper limit of normal value and continue to increase for 2 weeks);\n10. Steroid or immunosuppressive medicine for other diseases within 3 months, such as cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, tripterygium wilfordii, etc.\n11. With tumor, severe cardiac failure, severe hepatologic diseases, hematological diseases, or other severe system diseases.\n12. Patients who are known to be allergic to rituximab;\n13. History of transplantation, excluding cornea or hair transplantation;\n14. The attenuated live vaccine was inoculated within 1 month before enrollment;\n15. Patients who participated in other clinical trials within three months before enrollment;\n16. Patients are not suitable for inclusion in the trial by any investigator.",{"count":342,"type":22},80,[241],"The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.",[28,299],[299,347],"Glucocorticosteroids","2023-08-23",{"date":350,"type":46},"2023-08-25",{"date":352,"type":46},"2023-02-09",{"date":354,"type":22},"2026-07-30",{"name":256,"class":53}]