[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584500":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":62,"collaborators":64,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":25,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":25,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Dapagliflozin Group","EXPERIMENTAL","①Dapagliflozin+Standard Treatment for 12 weeks. Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily,with dose adjustment based on body weight.Standard Treatment:standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.),This combined therapy will be administered for 12 weeks.\n\n② Washout period for 4 weeks Participants should maintain RAASi therapy while discontinuing dapagliflozin.\n\n③RAASi monotherapy alone for an additional 12 weeks.",[13],"Drug: Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks，then Standard Treatment alone for12 weeks",{"label":15,"type":10,"description":16,"interventionNames":17},"Delayed Dapagliflozin Group","① Standard Treatment for 12 weeks Standard Treatment:Standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy alone for 12 weeks.(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.)\n\n② Washout period for 4 weeks Participants should maintain RAASi therapy without additional interventions.\n\n③ Dapagliflozin+Standard Treatment for 12 weeks Dapagliflozin therapy is administered orally once daily,with dose adjustment based on body weight.This combined therapy will be administered for 12 weeks.",[18],"Drug: Standard Treatment alone for 12 weeks ,washout period for 4 weeks ,then Dapagliflozin+Standard Treatment for 12 weeks",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks，then Standard Treatment alone for12 weeks","①Dapagliflozin+Standard Treatment for 12 weeks. Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily,with dose adjustment based on body weight: 5 mg\u002Fday for participants ≤30 kg; 5 mg\u002Fday initially (first week), then increased to 10 mg\u002Fday for participants \\>30 kg Standard Treatment:standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.),This combined therapy will be administered for 12 weeks.\n\n② Washout period for 4 weeks Participants should maintenance RAASi therapy while discontinuing dapagliflozin.\n\n③Standard Treatment alone for an additional 12 weeks. To ensure compliance, all participants are required to complete a daily medication log.If any adverse events (AEs) occur, appropriate clinical interventions will be promptly implemented",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Treatment alone for 12 weeks ,washout period for 4 weeks ,then Dapagliflozin+Standard Treatment for 12 weeks","①Standard Treatment for 12 weeks Standard Treatment:Standard renin-angiotensin-aldosterone system inhibitor (RAASi) therapy alone for 12 weeks.(The dosage will be maintained at the pre-enrollment level throughout the entire treatment period, with no adjustments made during therapy.)\n\n②Washout period for 4 weeks Participants should maintenance RAASi therapy while discontinuing dapagliflozin.\n\n③Dapagliflozin+Standard Treatment for 12 weeks Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily,with dose adjustment based on body weight: 5 mg\u002Fday for participants ≤30 kg; 5 mg\u002Fday initially (first week), then increased to 10 mg\u002Fday for participants \\>30 kg.This combined therapy will be administered for 12 weeks To ensure compliance, all participants are required to complete a daily medication log.If any adverse events (AEs) occur, appropriate clinical interventions will be promptly implemented",[15],[31],{"name":32,"affiliation":5,"role":33},"YIHUI ZHAI","STUDY_DIRECTOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+86-021-64932827","yhzhai@fudan.edu.cn",{"name":40,"role":36,"phone":37,"phoneExt":25,"email":41},"WEI ZHANG","zhangw421489@163.com",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57,58,60],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":37,"phoneExt":25,"email":59},"421579489@qq.com",{"name":32,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65,67,69,72,74,76,78,80,82,84,86,88,91,93,95,97,99,101,103,105],{"name":66,"class":6},"Guangzhou Women and Children's Medical Center",{"name":68,"class":6},"Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region",{"name":70,"class":71},"Shandong Provincial Hospital","OTHER_GOV",{"name":73,"class":6},"The First Affiliated Hospital of Henan University of Traditional Chinese Medicine",{"name":75,"class":6},"Wuhan Children's Hospital",{"name":77,"class":6},"Xuzhou Children Hospital",{"name":79,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":81,"class":6},"Kunming Children's Hospital",{"name":83,"class":6},"The Children's Hospital of Zhejiang University School of Medicine",{"name":85,"class":6},"Children's Hospital of Nanjing Medical University",{"name":87,"class":6},"Zhengzhou Children's Hospital, China",{"name":89,"class":90},"Xiamen Women's and Children's Hospital","UNKNOWN",{"name":92,"class":6},"Guiyang Maternity and Child Health Care Hospital",{"name":94,"class":6},"Maternal and Child Health Care Hospital of Hainan Province",{"name":96,"class":6},"Children's Hospital of The Capital Institute of Pediatrics",{"name":98,"class":6},"Second Affiliated Hospital of Wenzhou Medical University",{"name":100,"class":71},"Xian Children's Hospital",{"name":102,"class":6},"The Second Hospital of Hebei Medical University",{"name":104,"class":6},"Wuxi Women's & Children's Hospital",{"name":106,"class":90},"First People's Hospital of Urumqi","100584500","phase-3-the-efficacy-and-safety-of-dapagliflozin-in-the-treatment-of-hereditary-kidney-disease-with-proteinuria-in-children-100584500",false,"NCT06890143","The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children","The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children: a Prospective, Randomized Crossover Trial","Inclusion Criteria:\n\n* Confirmed diagnosis of hereditary kidney disease (identification of pathogenic genes through molecular genetic testing; for Alport syndrome, molecular diagnosis is not necessarily required if diagnosed based on clinical and pathological findings; for those with a clear family history and a high clinical suspicion of hereditary kidney disease).\n* 24 - hour urinary protein level \\> 0.2 g or urinary protein to creatinine ratio (UPCR) \\> 0.2 mg\u002Fmg.\n* Calculate the estimated glomerular filtration rate (eGFR) using the Schwartz formula (36.5 \\* height in cm \u002F serum creatinine in μmol\u002FL), with eGFR ≥ 60 ml\u002Fmin\u002F1.73 m².\n* Stable use of the basic treatment drug RAASi (including ACEI\u002FARB) for more than 4 weeks, and no dosage adjustment during the treatment period.\n* Willingness to sign the informed consent form.\n\nExclusion Criteria:Exclusion applies if any of the following criteria are met:\n\n* Treatment with hormones\u002Fimmunosuppressive agents within the previous 4 weeks.\n* Treatment with SGLT2 inhibitors within the previous 4 weeks.\n* Comorbid diabetes.\n* Uncontrolled urinary tract infection.\n* Evidence of urinary tract obstruction such as dysuria.\n* Blood pressure below the 5th percentile for the same gender, age, and height.\n* Organ transplantation.\n* Tumor.\n* Presence of any of the following definite evidence of liver disease: ALT\u002FAST reaching 2 times the normal value, hepatic encephalopathy, esophageal varices, or portal shunt surgery.\n* Comorbid medical conditions that may affect drug absorption, distribution, metabolism, and excretion, including but not limited to any of the following: active inflammatory bowel disease within the past 6 months, history of major gastrointestinal surgery (such as gastrectomy, gastroenterostomy, intestinal resection), gastrointestinal ulcer, gastrointestinal or rectal bleeding within the past 6 months, pancreatic injury or pancreatitis within the past 6 months.\n* Subjects at risk of dehydration or volume depletion, which may affect drug efficacy or safety.\n* Participation in other drug trials within the previous 4 weeks.\n* Blood loss exceeding 400 ml within the previous 8 weeks.\n* Poor past medication compliance or unwillingness to complete the trial.\n* Any other medical conditions that may place the patient at a higher risk due to participation in this study.","ALL","6 Years","18 Years",{"count":118,"type":119},44,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","This study is a multicenter, randomized controlled crossover trial aimed to evaluate the efficacy and safety of dapagliflozin in the treatment of hereditary kidney disease with proteinuria in children",[125],"Pediatric Hereditary Kidney Diseases",[127,128,129,130],"hereditary kidney diseases","proteinuria","dapagliflozin","children","2026-07-02",{"date":133,"type":134},"2026-07-06","ACTUAL",{"date":136,"type":134},"2025-03-22",{"date":138,"type":119},"2027-03-31",{"name":5,"class":6},1]