[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648292":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":163,"collaborators":166,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":26,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group (High-dose group)","ACTIVE_COMPARATOR","Standard high-dose glucocorticoid therapy",[13],"Drug: High-dose prednisone",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group (Low-dose group)","EXPERIMENTAL","Low-dose glucocorticoid therapy",[19],"Drug: Low-dose prednisone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","High-dose prednisone","All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg\u002Fkg\u002Fday for 3 consecutive days per course; maximum 500 mg\u002Fday). Participants will then be randomized in a 1:1 ratio to the two treatment groups.\n\nIn the standard-dose (control) group, oral prednisone will be initiated at 1.4-1.6 mg\u002Fkg\u002Fday (maximum 60 mg\u002Fday), followed by gradual tapering according to the predefined schedule. For participants weighing \\\u003C40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025.\n\nAll participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Low-dose prednisone","All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg\u002Fkg\u002Fday for 3 consecutive days per course; maximum 500 mg\u002Fday). Participants will then be randomized in a 1:1 ratio to the two treatment groups.\n\nParticipants in the intervention group will receive oral prednisone at an initial dose of 0.6-0.8 mg\u002Fkg\u002Fday, with a maximum dose of 30 mg\u002Fday, followed by gradual tapering according to the predefined schedule. For participants weighing \\\u003C40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025. The estimated cumulative prednisone dose over 24 weeks will be approximately 50% of that in the control group.\n\nAll participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.",[15],[32],{"name":33,"affiliation":34,"role":35},"Hongmei Song, MD, PhD","Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Sihao Gao, MD, PhD","CONTACT","86-10-69155727","sihao.gao@gmail.com",[43,60,71,87,102,117,132,147],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":61,"status":45,"city":46,"state":47,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Beijing Children's Hospital, Capital Medical University",{"type":52,"coordinates":63},[54,55],{"lat":55,"lon":54},[66,70],{"name":67,"role":39,"phone":68,"phoneExt":26,"email":69},"Huawei Mao, MD, PhD","86-10-59616318","maohwei@qq.com",{"name":67,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":72,"status":73,"city":74,"state":75,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Chidren's Hospital of Chongqing Medical University","NOT_YET_RECRUITING","Chongqing","Chongqing Municipality",{"type":52,"coordinates":77},[78,79],106.55771,29.56026,{"lat":79,"lon":78},[82,86],{"name":83,"role":39,"phone":84,"phoneExt":26,"email":85},"Xuemei Tang, MD","86-23-63630957","tangxuemei2008@163.com",{"name":83,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":88,"status":73,"city":89,"state":90,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Shenzhen Children's Hospital","Shenzhen","Guangdong",{"type":52,"coordinates":92},[93,94],114.0683,22.54554,{"lat":94,"lon":93},[97,101],{"name":98,"role":39,"phone":99,"phoneExt":26,"email":100},"Jun Yang, MD","86-75-58395620","rogasansz@163.com",{"name":98,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":103,"status":73,"city":104,"state":105,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"The Second Xiangya Hospital of Central South University","Changsha","Hunan",{"type":52,"coordinates":107},[108,109],112.97087,28.19874,{"lat":109,"lon":108},[112,116],{"name":113,"role":39,"phone":114,"phoneExt":26,"email":115},"Xiaochuan Wu, MD","86-731-85295259","wuxiaochuan@sina.com",{"name":113,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":118,"status":73,"city":119,"state":120,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Children's Hospital of Nanjing Medical University","Nanjing","Jiangsu",{"type":52,"coordinates":122},[123,124],118.77778,32.06167,{"lat":124,"lon":123},[127,131],{"name":128,"role":39,"phone":129,"phoneExt":26,"email":130},"Haiguo Yu, MD","86-25-83117830","yuhaiguo73@126.com",{"name":128,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":133,"status":73,"city":134,"state":135,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Jilin University","Changchun","Jilin",{"type":52,"coordinates":137},[138,139],125.32278,43.88,{"lat":139,"lon":138},[142,146],{"name":143,"role":39,"phone":144,"phoneExt":26,"email":145},"Sirui Yang, MD","86-431-88783761","sryang@jlu.edu.cn",{"name":143,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":148,"status":73,"city":149,"state":150,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Children's Hospital of Fudan University","Shanghai","Shanghai Municipality",{"type":52,"coordinates":152},[153,154],121.45806,31.22222,{"lat":154,"lon":153},[157,161],{"name":158,"role":39,"phone":159,"phoneExt":26,"email":160},"Li Sun, MD","86-21-64932829","lillysun@263.net",{"name":162,"role":35,"phone":26,"phoneExt":26,"email":26},"Li SUN, MD",{"type":35,"investigatorFullName":164,"investigatorTitle":165,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hongmei Song","Professor",[167,169,171,173,175,177,178],{"name":168,"class":6},"Children's Hospital of Chongqing Medical University",{"name":170,"class":6},"Beijing Children's Hospital",{"name":172,"class":6},"Second Xiangya Hospital of Central South University",{"name":88,"class":174},"OTHER_GOV",{"name":176,"class":6},"Nanjing Children's Hospital",{"name":133,"class":6},{"name":148,"class":6},"100648292","phase-4-childhood-onset-lupus-nephritis-initial-glucocorticoid-dose-harmonization-trial-light-trial-100648292",false,"NCT07719140","Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)","Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial","LIGHT","Inclusion Criteria:\n\n* Age ≥6 years and \\\u003C18 years, with body weight ≥20 kg\n* Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)\n* Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology \u002F Renal Pathology Society (ISN\u002FRPS) classification\n* At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg\u002Fkg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg\n* White blood cell count ≥3.0 × 10⁹\u002FL and lymphocyte count ≥1.0 × 10⁹\u002FL\n* No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg\u002Fday (or ≤1 mg\u002Fkg\u002Fday)\n* Written informed consent obtained and good treatment compliance expected\n\nExclusion Criteria:\n\n* Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency\n* Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.\n* Severe neuropsychiatric lupus\n* Peripheral blood hemoglobin \\\u003C60 g\u002FL, platelet count \\\u003C10 × 10⁹\u002FL, or concomitant aplastic anemia\n* Severe cardiac insufficiency (NYHA functional class ≥ II)\n* Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m²\n* Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions\n* Patients deemed by the investigator to be unsuitable for participation in this trial","ALL","6 Years","18 Years",{"count":191,"type":192},198,"ESTIMATED","INTERVENTIONAL",[195],"PHASE4","Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes.\n\nGlucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg\u002Fkg\u002Fday. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity.\n\nBecause cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.",[198,199],"Childhood-onset Systemic Lupus Erythematosus","Lupus Nephritis (LN)",[201,202,203,204,205],"Children","Systemic lupus erythematosus","Lupus nephritis","Glucocorticoid","Therapy","2026-07-17",{"date":208,"type":209},"2026-07-22","ACTUAL",{"date":211,"type":192},"2026-07",{"date":213,"type":192},"2029-03",{"name":5,"class":6},8]