To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
Target patients aged 18-75, including those aged 18 and 75
Primary IgA nephropathy diagnosed by renal biopsy within 3 months
eGFR≥30ml/min/1.73m2
24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
Patients who have received kidney transplantation or dialysis
Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema)
Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure\<140/90mmHg
Cohort
Prospective
Gd-IgA1 test
Other interventioncollect and test Gd-IgA1 test in enrolled subjects
The changes in proteinuria levels
To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Safety event
Evaluate the changes in eGFR of target patients at the 12th month compared to baseline
Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline
Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients
Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month
Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline.
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