A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

Exclusion Criteria18

• 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
• Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%)
• Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
• Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
• Patients diagnosed with malignant tumors within the past 5 years
• Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
• Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
• Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
• Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
• Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
• Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
• Current or previous (within the past 2 years) alcoholism or drug abuse;
• Expected lifespan\<5 years
• During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
• Researchers believe that patients who are not suitable for treatment with Nefecon