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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07354503
Eligibility Criteria:
Inclusion Criteria:
1. Age 3-17 years;
2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;
3. Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol);
4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m².
5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).
Exclusion Criteria:
1. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;
2. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000/μL); moderate to severe anemia (hemoglobin \<9.0 g/dL); thrombocytopenia (platelet count \<100×10\^12/L); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);
3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;
4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);
5. Subjects with severe osteoporosis requiring treatment;
6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;
7. Subjects who have received B-cell targeted therapy within the last 6 months;
8. History of major organ transplant or hematopoietic stem cell/cell/bone marrow or kidney transplant;
9. Vaccination with live attenuated vaccines within 1 month prior to treatment;
10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol);
11. Incomplete clinical data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT07354503
Study Brief:
Protocol Section:
NCT07354503