Comparing mycophenolate mofetil and cyclophosphamide for treating pediatric lupus nephritis

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

This study is testing whether mycophenolate mofetil or cyclophosphamide works better and is safer for treating kidney problems in children with lupus.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (other)
• Drugs / interventions: rituximab, baileyoumab, methotrexate, cyclophosphamide
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05495893 on ClinicalTrials.gov

What this trial studies

This study is a prospective, randomized, multicenter, open-label trial aimed at comparing the effectiveness and safety of mycophenolate mofetil (MMF) versus cyclophosphamide (CYC) in the induction therapy of pediatric patients with active proliferative lupus nephritis. The research focuses on children aged 5-17 years who meet specific criteria for systemic lupus erythematosus and active proliferative lupus nephritis. By conducting this study across multiple centers in China, the researchers aim to gather comprehensive data on the efficacy of these treatments in a pediatric population, which has been underrepresented in previous studies.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5-17 years diagnosed with active proliferative lupus nephritis who meet specific inclusion criteria.

Not a fit: Patients with a known history of primary immunodeficiency or those who have previously received certain immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the most effective treatment for pediatric patients with lupus nephritis, potentially improving their health outcomes.

How similar studies have performed: While there is limited data on the use of MMF and CYC in children, previous studies in adults have shown both treatments to be effective, making this approach novel in the pediatric context.

Eligibility 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.

Where this trial is running

Changsha, Hunan

• the Second Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Xiaochuan Wu

Conditions: Mycophenolate Mofetil, Cyclophosphamide, Lupus Nephritis