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NCT07675291
Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children
Conditions: Lupus Nephritis
Sex: All
Ages: 3 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: Nanfang Hospital, Southern Medical University
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.
Eligibility Criteria
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\
Source: ClinicalTrials.gov (NCT07675291). StuddyBuddy aggregates publicly available trial information.