Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis
Summary
The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2024-03-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 1500 mg | — |
| Background | Methylprednisolone | Other / unclassified | 3000 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Background | Mycophenolate Mofetil | Small molecule | 1.5 g | Oral |
| Background | Tacrolimus | Small molecule | 2 mg | Oral |
| Background | Tacrolimus | Small molecule | 4 mg | Oral |