Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT05495893
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT05495893
Study Brief:
Protocol Section:
NCT05495893