Rituximab
DrugRituximab is given monthly (375m/m2;maximum 500mg) for 6 doses
NCT Number: NCT07675291
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.
Trial opening soon.
Get Notified3 year–18 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months after the intervention
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
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 is defined as failure to achieve partial or complete response.
Time frame: 6 months after the intervention
SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)2000.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children
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