lupus nephritis
Conditions
Interventions
Intervention Group:In addition to conventional therapy, daratumumab 800 mg will be administered every two weeks for a total of four doses
Control group:Standard therapy plus belimumab 10 mg/kg on Days 0, 14, and 28, then every 4 weeks for 104 weeks.
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years; 2. Diagnosed with systemic lupus erythematosus (SLE) with positive autoantibodies (antinuclear antibody titer >=1:80, anti–double-stranded DNA antibody, or both); 3. Fulfillment of the 1997 American College of Rheumatology (ACR) classification criteria for SLE; 4. 24-hour urinary protein >=1 g; 5. Biopsy-proven lupus nephritis classified as class III (focal lupus nephritis) or class IV (diffuse lupus nephritis), with or without concomitant class V (membranous lupus nephritis), according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification; 6. Renal biopsy specimen demonstrating active lesions or a combination of active and chronic lesions; 7. Provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Body weight less than 40 kg; 2. Severe infections or other life-threatening complications; 3. Severe lupus activity, such as neuropsychiatric systemic lupus erythematosus (NPSLE); 4. Significant hematologic disorders or abnormal laboratory findings (white blood cell count 2 times the upper limit of normal, unless attributable to SLE); 9. Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m²; 10. Use of cyclophosphamide or mycophenolate mofetil as induction therapy for more than 1 month within the past 3 months; 11. History of alcohol abuse; 12. Compensated heart failure or severe hypertension; 13. Pregnant or breastfeeding women, or individuals unwilling to use effective contraception; 14. Coexisting connective tissue diseases; 15. Patients with mental illness; 16. Epilepsy and other neurological disorders; 17. History of previous tumors; 18. Patients with poor medication adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Partial Remission Rate;serum albumin;serum creatinine;24-hour urinary protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count; | — |
Countries
China
Contacts
Public ContactYanfang Xu
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed