IgA vasculitis nephritis
Conditions
Interventions
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion 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 m^2; 5.Renal biopsy is optional (if a renal biopsy is performed, cases classified as ISKDC grade >=IV must be excluded);
Exclusion criteria
Exclusion criteria: 1.Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, 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 (ALT, 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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in total B and natural killer (TBNK) cells during long-term follow-up;Compared to the baseline, changes in 24-hour urine protein quantification and urine protein-to-creatinine ratio (UPCR) were evaluated at weeks 12, 24, and 48 after medication administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum immunoglobulin levels (IgG, IgA, IgM) ?C3 and C4 during long-term follow-up;Changes in estimated glomerular filtration rate (eGFR) during long-term follow-up;Changes in urinary red blood cell count (cells/µL) during long-term follow-up;Cumulative glucocorticoid dosage;Incidence and severity of all adverse events; | — |
Countries
China
Contacts
Public ContactMao Jianhua
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed