IgA nephropathy
Conditions
Interventions
IgAN Grade I (Lee Grade):Background Therapy + Telitacicept
IgAN Grade II (Lee Grade):Background Therapy + Telitacicept
IgAN Grade III (Lee Grade):Background Therapy + Telitacicept
IgAN Grade IV (Lee Grade):Background Therapy + Telitacicept
IgAN Grade V (Lee Grade):Background Therapy + Telitacicept
Sponsors
The Second Affiliated Hospital of Shantou University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form; 2.Histologically confirmed IgAN by renal biopsy within 2 years prior to enrollment; Patients who have failed at least 6 months of conventional therapy post-biopsy are eligible; 3.Male or female, aged between 18 and 70 years; 4.Urine protein-to-creatinine ratio (UPCR) >= 1000 mg/g from two separate tests prior to randomization, or 24-hour urinary protein excretion >= 1.0 g/24h; 5.Estimated glomerular filtration rate (eGFR) greater than 35 mL/min/1.73 m^2, as calculated by the CKD-EPI equation.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1.Clinically significant laboratory abnormalities, including but not limited to (Parameter / Abnormality Standard): (1).White Blood Cell Count: 1.5 × ULN; (6).ALT: >3 × ULN; (7).AST: >3 × ULNAlkaline Phosphatase: >2 × ULN; (8).Creatine Kinase: >5 × ULN; 2.Etiology of secondary IgA nephropathy, including: Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, rheumatoid arthritis, mixed connective tissue disease, polyarteritis nodosa, erythema nodosum, psoriasis, ulcerative colitis, Crohn's disease, malignancy, AIDS, etc; 3.Any renal disease with specific pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis (>50% glomeruli on biopsy), or IgA nephropathy with minimal change disease (MCD-IgAN); or requiring corticosteroid therapy for IgAN; 4.Cardiovascular or cerebrovascular events within the past 12 weeks (e.g., myocardial infarction, unstable angina, ventricular arrhythmias, New York Heart Association Class II-IV heart failure, stroke, etc.); 5.Active tuberculosis or latent tuberculosis infection; 6.Herpes zoster infection, positive HIV antibody, or positive HCV antibody; 7.Active hepatitis or severe liver disease, as well as HBV infection (based on HBV screening: 1. Exclude HBsAg-positive subjects; 2. For HBsAg-negative and HBcAb-positive subjects, HBV-DNA must be tested: exclude HBV-DNA-positive subjects; those with negative HBV-DNA may enroll but must initiate anti-HBV prophylaxis). 8.Patients with a history of malignancy; 9.Pregnancy, lactation, or patients planning for pregnancy during the study period; 10.Patients requiring treatment with nephrotoxic drugs during the study period; 11.Known hypersensitivity to human-derived biological products; 12.Administration of any other investigational drug within four weeks prior to enrollment or within five times the half-life of the investigational drug (whichever is longer); 13.Any other condition deemed by the investigator to make the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine urinalysis;Complete Blood Count;Galactose-deficient IgA1;Lymphocyte Subsets;Immunoglobulin;Estimated glomerular filtration rate;Urine protein-to-creatinine ratio;Complement;Albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Enzymes;Serum Creatinine;Urea;Uric Acid;Blood lipids;Electrolytes;C-reactive protein;Parathyroid Hormone; | — |
Countries
China
Contacts
Public ContactTianbiao Zhou
The Second Affiliated Hospital of Shantou University Medical College
Outcome results
None listed