Clinical trial NCT05495893: MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mycophenolate Mofetil
Cyclophosphamide
Lupus Nephritis
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Children's Hospital of Chongqing Medical University
name: Beijing Children's Hospital
name: Jiangxi Province Children's Hospital
name: The Affiliated Hospital of Qingdao University
name: Shenzhen Children's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: The Children's Hospital of Zhejiang University School of Medicine
name: The Second Hospital of Hebei Medical University
First posted: 2022-08-10
Enrollment: 224
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

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.

Primary outcomes:
measure: Effective rate of LN treatment
timeFrame: 6 months
Secondary outcomes:
measure: complete remission time
timeFrame: 6 months
measure: Incidence of LN treatment failure
timeFrame: 6 months
measure: Incidence of creatinine doubling
timeFrame: 6 months
measure: LN recurrence rate
timeFrame: 6 months
measure: SLE recurrence rate
timeFrame: 6 months
measure: SLE disease activity score
timeFrame: 6 months
measure: partial remission time
timeFrame: 6 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Second Xiangya Hospital, Central South University
name: Xiaochuan Wu
role: STUDY_CHAIR
References: