IgAN
Conditions
Interventions
1:Telitacicept+prednisone
2:prednisone
Sponsors
Xijing hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign informed consent; 2) IgA nephropathy was confirmed by pathological biopsy; 3) Age =18 years old, =75 years old, male or female; 4) 24-hour urinary protein =1g; 5) Estimated glomerular filtration rate (eGFR, using CKD-EPI formula) >30mL/min/1.73m2. 1) Voluntarily sign informed consent; 2) IgA nephropathy was confirmed by pathological biopsy; 3) Age =18 years old, =75 years old, male or female; 4) 24-hour urinary protein =1g; 5) Estimated glomerular filtration rate (eGFR, using CKD-EPI formula) >30mL/min/1.73m2.
Exclusion criteria
Exclusion criteria: 1) Abnormal laboratory indicators that require the subject to be excluded, including but not limited to the following: White blood cell count 1.5×ULN; e. Glutamic-pyruvic transaminase > 3×ULN; f. Glutamic oxalacetic transaminase > 3×ULN; g. Alkaline phosphatase > 2×ULN; h. creatine kinase > 5×ULN. 2) Exclude secondary IgA nephropathy, including: anaphylactoid purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, mixed connective tissue disease; 3) Exclude nephrotic syndrome, crescent body nephritis (pathological diagnosis of crescent body >50%), minimal degenerative nephropathy with IgA deposition and other special pathological or clinical kidney disease types; 4) Patients who experienced any of the following cardiovascular and cerebrovascular events in the 12 weeks prior to screening: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association Class II or higher heart failure, stroke, etc. 5) In the 2 visits during the screening period, at least 1 outpatient sitting SBP>140 mmHg; DBP>90 mmHg; 6) Patients with diabetes (including type I and type II diabetes); 7) BMI >28 kg/m2; 8) Systemic use of immunosuppressive biologics, including rituximab, Beliuzumab, Autolumab, acercept, and tetacercept, within 12 weeks prior to the first administration; 9) Systemic glucocorticoid therapy within 12 weeks prior to initial medication, excluding the following: systemic glucocorticoid therapy not exceeding 7.5mg/ day of prednisone or equivalent doses of other drugs of the same class; 10) Patients requiring hospitalization due to active infection or intravenous anti-infection treatment within 4 weeks before the first medication; 11) Patients with active tuberculosis and untreated latent tuberculosis; 12) Patients with active hepatitis or latent viral hepatitis (including HBsAg positive patients, HBcAb positive patients with HBV-DNA positive patients, HCV-RNA positive patients); 13) A history of immunodeficiency or a positive HIV test (enzyme-linked immunosorbent assay and western blot); 14) Patients diagnosed with malignant tumors within the past 5 years; 15) Patients receiving kidney transplantation; 16) Pregnant and lactating women and men or women who have a family plan during the trial; 17) Patients who cannot avoid nephrotoxic drugs during the trial; 18) Allergic to human biological products; 19) Patients who have been given any investigational drug within 4 weeks prior to the first dose or 5 times the half-life of the investigational drug (longer time to take); 20) Subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hour urine protein; | — |
Countries
China
Contacts
Public ContactXu Guoshuang
Xijing hospital
Outcome results
None listed