Efficacy and Safety of CD20 Monoclonal Antibody Combined with Tacrolimus versus Standard of Care in Active Lupus Nephritis: a Randomized, Open-label, Exploratory Study

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Combination therapy group:CD20 monoclonal antibody + tacrolimus;Control group:glucocorticoids + mycophenolate sodium; CONDITION: lupus nephritis PRIMARY OUTCOME: Complete renal response rate; SECONDARY OUTCOME: urine protein;serum creatinine;serum albumin;estimated glomerular filtration rate (eGFR);Systemic Lupus Erythematosus Disease Activity Inde X2000 (SLEDAI‐2K) score;complement C3;complement C4; INCLUSION CRITERIA: 1. Age between 18 and 70 years old. 2. Diagnosed with SLE according to the 2019 EULAR/ACR criteria. 3. Active class III, IV, V, or mixed (III+V, IV+V) lupus nephritis confirmed by renal biopsy based on the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification. 4. 24‐hour urinary protein =0.8 g/day or urinary albumin‐to‐creatinine ratio (UACR) =0.8 g/g during the screening period. 5. Systemic Lupus Erythematosus Disease Activity Inde X2000 (SLEDAI‐2K) score =8 during the screening period. 6. Female participants of childbearing potential and male participants must use highly effective contraceptive methods throughout the clinical study. 7. Participants are willing to participate in this study and sign the written informed consent form.
Epistemonikos ID: 599ef7f1f330df17246b7109f60d32c6136817b9
First added on: Oct 08, 2026