The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Rituximab is given monthly (375m/m2;maximum 500mg) for 6 doses
The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months.
The therapy for cyclophosphamide is 750mg/m2(maximum 1000mg) every month for 6 doses.
Complete response
Patients are defined as having a complete response if they meet all the following conditions: ①Proteinuria is \<0.5 g/1.73m\^2 per day or protein-creatinine ratio from a morning spot urine \<0.2 g/g ②Renal function is stabilized or improved(±10%-15% of baseline)
Time frame: 6 months after the intervention
Partial response
A partial response is defined for patients who do not meet the complete response criteria but satisfy both of the following criteria: ①Urinary protein is reduced by ≥ 50% from baseline, and protein-creatinine ratio from a morning spot urine \< 3.0g/g ②Renal function is stable or improved(±10%-15% of baseline).
Time frame: 6 months after the intervention
No kidney response
No kidney response is defined as failure to achieve partial or complete response.
Time frame: 6 months after the intervention
SLEDAI scores
SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)2000.
Time frame: 6 months after the intervention
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ACEI/ARB is recommended as the basic therapy for lupus nephritis.
Corticosteroid is recommended as the basic therapy for lupus nephritis.
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.