Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rituximab, Mycophenolate Mofetil (MMF) Treatment, Cyclophosphamide, ACEI / ARB.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children
Overview
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.
Interventions
- Drug rituximab
Rituximab is given monthly (375m/m2；maximum 500mg) for 6 doses - Drug Mycophenolate Mofetil (MMF) Treatment
The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months. - Drug Cyclophosphamide
The therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses. - Drug ACEI / ARB
ACEI/ARB is recommended as the basic therapy for lupus nephritis. - Drug Corticosteroid
Corticosteroid is recommended as the basic therapy for lupus nephritis. - Drug Hydroxychloroquine (HCQ)
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.
Primary outcome measures
- Complete response [Time frame: 6 months after the intervention]
- Partial response [Time frame: 6 months after the intervention]
- No kidney response [Time frame: 6 months after the intervention]
Secondary outcome measures (1)
- SLEDAI scores [Time frame: 6 months after the intervention]
Eligibility criteria
Inclusion criteria
- Children aged 3-18 years old, regardless of sex;
- SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria;
- Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);
- White blood cell count ≥3.0×10\^9/L, and lymphocyte count ≥ 0.5× 10\^9/L and CD20 (or CD19)≥1/ul;
- No cyclophosphamide or rituximab induction therapy was used before enrollment;
- Informed consent form is signed by the guardian and children over 8 years old;
- In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg;
- Estimated GFR≥60ml/min/1.73m\^2 (improved Swchartz formula).
Exclusion criteria
- Patients with lupus encephalopathy;
- Estimated GFR<60ml/min/1.73m\^2(Swchartz formula);
- HBV-antigen positive, HCV or HIV antibody positive;
- Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;
- Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;
- Severe heart failure and liver function damage;
- Patients who is not suitable to participate in this study judged by the researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07675291 · NEFC-2025-711