Lupus Nephritis
Conditions
Brief summary
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
DRUGrituximab
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.
DRUGCyclophosphamide
The therapy for cyclophosphamide is 750mg/m2（maximum 1000mg） every month for 6 doses.
DRUGACEI / ARB
ACEI/ARB is recommended as the basic therapy for lupus nephritis.
DRUGCorticosteroid
Corticosteroid is recommended as the basic therapy for lupus nephritis.
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 3-18 years old, regardless of sex; 2. SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria; 3. Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V); 4. White blood cell count ≥3.0×10\^9/L, and lymphocyte count ≥ 0.5× 10\^9/L and CD20 (or CD19)≥1/ul; 5. No cyclophosphamide or rituximab induction therapy was used before enrollment; 6. Informed consent form is signed by the guardian and children over 8 years old; 7. In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg; 8. Estimated GFR≥60ml/min/1.73m\^2 (improved Swchartz formula).
Exclusion criteria
1. Patients with lupus encephalopathy; 2. Estimated GFR\<60ml/min/1.73m\^2(Swchartz formula); 3. HBV-antigen positive, HCV or HIV antibody positive; 4. Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis; 5. Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide; 6. Severe heart failure and liver function damage; 7. Patients who is not suitable to participate in this study judged by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | 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） |
| Partial response | 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）. |
| No kidney response | 6 months after the intervention | No kidney response is defined as failure to achieve partial or complete response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SLEDAI scores | 6 months after the intervention | SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index（SLEDAI）2000. |
Contacts
CONTACTLiangzhong Sun
Outcome results
None listed