Overview

A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population

Eligibility

Inclusion Criteria:

        Only those who fully meet the following criteria can be considered for inclusion in this
        study:
          1. Age 5-17 years old;
          2. SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012
             SLICC diagnostic criteria;
          3. According to the revised International Society of Nephrology / Society of renal
             pathology (isn/rps) classification in 2018, it conforms to active proliferative ln
             type III or IV, with or without type V;
          4. Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
          5. 24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine
             1.0mg/mg;
          6. Blood routine WBC count ≥ 3.010^9/l, lymphocyte ≥ 0.510^9/l before enrollment;
          7. No immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine A,
             tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab,
             baileyoumab, and etaxel were used before enrollment.
        Exclusion Criteria:
          1. A known history of primary immunodeficiency, splenectomy, or any potential disease
             that makes participants vulnerable to infection;
          2. Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection,
             severe fungal infection, or other serious infections;
          3. Have any history of tumor or cancer;
          4. Patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic
             anemia, blood routine platelet count lower than 10.0*10^9/l, glomerular filtration
             rate eGFR < 60 ml/min/1.73 m2, or patients with other serious complications have
             unstable vital signs;
          5. Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood,
             endocrine system diseases;
          6. Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide,
             glucocorticoids or any of the above drugs;
          7. Patients who participated in other clinical trials within 3 months before enrollment;
          8. The researcher judged that the patient's condition was not suitable for participants
             in this trial.