MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN

Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Therapy of Pediatric Patients With Active Proliferative Lupus Nephritis: A Prospective, Randomized, Multicenter, Open-label, Parallel-arm Study

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

Scattered research in adults showed that both mycophenolate mofetil (MMF) and cyclophosphamide (CYC) can be used in the induction therapy of lupus nephritis. however data is limited in children.Therefore, the purpose of this study is to observe and compare the efficacy and safety of MMF and CYC as induction therapy for children with proliferative lupus nephritis through a multi-center open randomized controlled study.

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 ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/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.