[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599952":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":86,"collaborators":88,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":32,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":62,"whyStopped":32,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab","EXPERIMENTAL","Participants in the experimental arm will receive subcutaneous Dupilumab for 24 weeks at the following weight-based doses, which are identical to doses used in the treatment of atopic dermatitis (higher than that for asthma), i.e.\n\n* Regime A (15 to \\\u003C30kg): 600mg once, then 300mg every 28 days x 5 doses.\n* Regime B (30 to \\\u003C60kg): 400mg once, then 200mg every 14 days x 11 doses.\n* Regime C (60kg or more): 600mg once, then 300mg every 14 days x 11 doses.",[13,14],"Biological: Dupilumab","Drug: Co-intervention of Prednisolone wean during randomised controlled phase",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Participants in the control arm will receive a subcutaneous injection of matched placebo (normal saline) at the same dosing intervals as the experimental arm for 24 weeks.",[20,14],"Drug: Placebo",{"label":22,"type":6,"description":23,"interventionNames":24},"Open label extension phase","On relapse, participants will be unmasked. Participants who were randomised to the placebo group will be invited to enrol into an open label extension phase. Participants will receive dupilumab in a regime identical to the experimental arm.",[25,26],"Biological: Dupilumab open label extension phase","Drug: Co-intervention of Prednisolone wean during open label extension phase",[28,33,37,41,45],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","Subcutaneous injection of Dupilumab for 24 weeks (weight based dosing)",[9],null,{"type":34,"name":16,"description":35,"armGroupLabels":36,"otherNames":32},"DRUG","Subcutaneous injection of normal saline placebo (matching dupilumab subcutaneous injection dosing) for 24 weeks",[16],{"type":34,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Co-intervention of Prednisolone wean during randomised controlled phase","The Prednisolone wean will commence 2 weeks after receiving the loading dose of Dupilumab\u002Fplacebo, with each weaning step 2 weeks apart. Prednisolone will be first weaned to the same dose every other day, if the current dosing is daily (or more frequent). The dose will subsequently weaned to 4 pre-determined levels of 30mg\u002Fm2, 15mg\u002Fm2, 10mg\u002Fm2 and 5mg\u002Fm2 every other day, rounding up to the nearest 5mg. For instance, if the current dose of prednisolone is 12mg\u002Fm2 every other day, the patient will decrease the dose to 10mg\u002Fm2 every other day for 2 weeks, followed by 5mg\u002Fm2 every other day for 2 weeks, before discontinuing the drug.\n\nIf patients enter the trial on Mycophenolate or Levamisole, this will be continued for the duration of the trial at the same dose.",[9,16],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Dupilumab open label extension phase","Upon nephrotic relapse, participants will be unmasked. If they were given placebo, they will be invited to enrol in an open label extension phase to receive dupilumab for 24 weeks (with dosing identical to the experimental arm).",[22],{"type":34,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"Co-intervention of Prednisolone wean during open label extension phase","Patients will also receive prednisolone 60mg\u002Fm2\u002Fday as a single daily dose (max 60-80mg OD according to physician's discretion) until in remission for 3 days, before prednisolone is weaned to 40mg\u002Fm2 every other day for 2 weeks. Doses should be rounded up to nearest 5mg where possible. Prednisolone will then be weaned in steps as per the randomised controlled phase. If patients do not enter full remission after 2 weeks from enrolment into the extension phase, they will be removed from the study. Additional agents, e.g. Mycophenolate, Levamisole, Calcineurin inhibitors should not be started during this time unless there is strong clinical indication.",[22],[50],{"name":51,"affiliation":5,"role":52},"Hui Kim Yap","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},"David Lu","CONTACT","+65 8044 1290","david_lu@nuhs.edu.sg",[60,75],{"facility":61,"status":62,"city":63,"state":63,"zip":64,"country":63,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"National University Hospital","RECRUITING","Singapore","119228","SG",{"type":67,"coordinates":68},"Point",[69,70],103.85007,1.28967,{"lat":70,"lon":69},[73,74],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},{"name":55,"role":52,"phone":32,"phoneExt":32,"email":32},{"facility":76,"status":62,"city":63,"state":63,"zip":77,"country":63,"countryCode":65,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"KK Women's and Children's Hospital","229899",{"type":67,"coordinates":79},[69,70],{"lat":70,"lon":69},[82,85],{"name":83,"role":56,"phone":57,"phoneExt":32,"email":84},"Celeste Jia Ying Yap","celeste.yap.j.y@singhealth.com.sg",{"name":83,"role":52,"phone":32,"phoneExt":32,"email":32},{"type":87,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[89,92,93],{"name":90,"class":91},"National Medical Research Council (NMRC), Singapore","OTHER_GOV",{"name":76,"class":91},{"name":94,"class":6},"National University of Singapore","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":107,"type":108},66,"ESTIMATED","INTERVENTIONAL",[111],"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.",[114,115],"Nephrotic Syndrome in Children","Nephrotic Syndrome Steroid-Dependent",[9,117,118,119,120],"Steroid sensitive nephrotic syndrome","Steroid dependent nephrotic syndrome","Frequently relapsing nephrotic syndrome","Paediatric","2025-11-27",{"date":123,"type":124},"2025-12-05","ACTUAL",{"date":121,"type":124},{"date":127,"type":108},"2028-02-28",{"name":5,"class":6},2]