Condition: Childhood-onset Systemic Lupus Erythematosus · Lupus Nephritis (LN) · Sponsor: Peking Union Medical College Hospital
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. Glucocorticoids 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/kg/day. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity. Because 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.
This description comes directly from the study's public registry record.
Sihao Gao, MD, PhD · 86-10-69155727 · sihao.gao@gmail.com
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| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing, Beijing Municipality, China | Recruiting |
| Beijing Children's Hospital, Capital Medical University | Beijing, Beijing Municipality, China | Recruiting |
| Chidren's Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Not Yet Recruiting |
| Shenzhen Children's Hospital | Shenzhen, Guangdong, China | Not Yet Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha, Hunan, China | Not Yet Recruiting |
| Children's Hospital of Nanjing Medical University | Nanjing, Jiangsu, China | Not Yet Recruiting |
| Jilin University | Changchun, Jilin, China | Not Yet Recruiting |
| Children's Hospital of Fudan University | Shanghai, Shanghai Municipality, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07719140