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

• Status: Recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Beijing Children's Hospital; Children's Hospital of Chongqing Medical University; Jiangxi Province Children's Hospital; Peking Union Medical College Hospital; Shenzhen Children's Hospital; The Affiliated Hospital of Qingdao University; The Children's Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Zhengzhou University; The Second Hospital of Hebei Medical University
• Treatments: Cyclophosphamide; Mycophenolic Acid

Criteria

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.