MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN (MyCITS)
Mycophenolate Mofetil, Cyclophosphamide, Lupus Nephritis
About this trial
This is an interventional treatment trial for Mycophenolate Mofetil
Eligibility Criteria
Inclusion Criteria:
Only those who fully meet the following criteria can be considered for inclusion in this study:
- Age 5-17 years old;
- SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
- 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;
- Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
- 24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;
- Blood routine WBC count ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/l before enrollment;
- 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:
- A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
- Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
- Have any history of tumor or cancer;
- 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;
- Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;
- Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;
- Patients who participated in other clinical trials within 3 months before enrollment;
- The researcher judged that the patient's condition was not suitable for participants in this trial.
Sites / Locations
- the Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cyclophosphamide
Mycophenolate mofetil
Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day
Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day