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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Methylprednisolone pulse therapy, total dose from 1500mg to 3000mg.
Belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks for 24 weeks.
1. Mycophenolate Mofetil, oral, 1.0-1.5g per day; 2. Tacrolimus, oral, 2-4mg per day.
Jiong Zhang
Nanjing, Jiangsu, China
RECRUITINGProportion of patients with a cumulative complete response at week 24 of treatment.
Complete response will be defined as below: 1. urinary protein less than 0.4g/24h 2. no active urinary sediment 3. serum albumin more than 3.5g/dl 4. and normal SCr.
Time frame: 24 weeks
The proportion of patients with partial response and non-response to treatment.
Partial response will be defined as a decrease of more than 50% of the baseline value of urinary protein and less than 3.5g/24h of urinary protein, a decrease of more than 50% of the baseline value of urinary sediment red blood cell count, and a normal or an increase of less than 30% of serum creatinine
Time frame: 24 weeks
Overall response rate at 24 weeks.
These will include complete remission and partial remission
Time frame: 24 weeks
Improvement of clinical indicators.
Clinical improvement of the disease was assessed using systemic lupus erythematosus disease activity index.
Time frame: 24 weeks
The changes of B cells.
The changes of CD20 number in peripheral blood will be observed and investigated.
Time frame: 24 weeks
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