IgA Nephropathy
Conditions
Interventions
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age: 16–60 years (inclusive), regardless of gender. 2. Diagnosis of IgA nephropathy confirmed by renal biopsy. 3. After 12 weeks of stable baseline therapy prior to the first dose (including ACEI/ARB treatment; patients intolerant to ACEI/ARB may be enrolled), still meeting any of the following urinary abnormalities:Urine occult blood >=1+ AND urine sediment microscopic red blood cell count >5/high-power field or urine RBC count >8000/mL; Urinary dysmorphic red blood cells proportion >70%, with or without proteinuria. 4. Signed informed consent form, demonstrating understanding and willingness to comply with study requirements and procedures.
Exclusion criteria
Exclusion criteria: 1. Any specific pathological or clinical types of nephropathy, such as nephrotic syndrome, crescentic glomerulonephritis, IgA nephropathy with minimal change disease (MCD-IgAN), or hematuria due to other causes (e.g., renal calculi, infection, nutcracker syndrome). 2. Estimated glomerular filtration rate (eGFR) 1.5 × ULN,Alanine aminotransferase (ALT) >3 × ULN,Aspartate aminotransferase (AST) >3 × ULN 4. Major cardiovascular or cerebrovascular events within the past 12 weeks (e.g., myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association [NYHA] Class II–IV heart failure, stroke). 5. Requirement for systemic corticosteroid therapy within 4 weeks prior to screening (excluding topical or nasal steroids); or receipt of systemic immunosuppressive therapy within 3 months prior to randomization (e.g., cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, or Tripterygium wilfordiipreparations). 6. Active infection requiring hospitalization or intravenous antibiotic therapy within 3 months prior to screening, or evidence of active tuberculosis at screening. 7. Active hepatitis or severe liver disease, and HBV infection (per HBV screening protocol: i. exclude HBsAg-positive subjects; ii. for HBsAg-negative and HBcAb-positive subjects, perform HBV-DNA testing—exclude those with positive HBV-DNA; subjects with negative HBV-DNA are eligible). 8. Other autoimmune diseases. 9. Pregnancy, lactation, or intention to conceive during the study period. 10. Receipt of any other investigational drug within 12 weeks prior to screening or within five times the half-life of the investigational drug (whichever is longer). 11. Any other condition considered by the Investigator to render the subject unsuitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine Occult Blood;Urine Red Blood Cell Count;uRBC change with TA; | — |
Secondary
| Measure | Time frame |
|---|---|
| proteinuria;estimated glomerular filtration rate ; | — |
Countries
China
Contacts
Public ContactHao Zhang
The Third Xiangya Hospital, Central South University
Outcome results
None listed