About this trial
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.
Eligibility criteria
Qualifiers
Age ≥6 years and <18 years, with body weight ≥20 kg
Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology / Renal Pathology Society (ISN/RPS) classification
At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg/kg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g
Disqualifiers
Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency
Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.
Severe neuropsychiatric lupus
Peripheral blood hemoglobin <60 g/L, platelet count <10 × 10⁹/L, or concomitant aplastic anemia
Trial design
Treatments tested in this trial
- High-dose prednisone
- Low-dose prednisone
Treatment groups
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Children's Hospital of Chongqing Medical University
Collaborator
Beijing Children's Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Shenzhen Children's Hospital
Collaborator
Nanjing Children's Hospital
Collaborator
Jilin University
Collaborator
Children's Hospital of Fudan University
Collaborator