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.
Inclusion Criteria:
Exclusion Criteria:
sihao.gao@gmail.com86-10-69155727
Standard high-dose glucocorticoid therapy
Low-dose glucocorticoid therapy
Beijing, Beijing Municipality 100730, China
sihao.gao@gmail.com86-10-69155727
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
maohwei@qq.com86-10-59616318
tangxuemei2008@163.com86-23-63630957
rogasansz@163.com86-75-58395620
wuxiaochuan@sina.com86-731-85295259
yuhaiguo73@126.com86-25-83117830
sryang@jlu.edu.cn86-431-88783761
lillysun@263.net86-21-64932829
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