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

Korábbi kezelés

• Patients who have received kidney transplantation or dialysis
• 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;
• Researchers believe that patients who are not suitable for treatment with Nefecon

Más betegség

• Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
• Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
• Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
• 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

Laborértékek

• 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 type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%)

Életkor

• Expected lifespan<5 years

Egyéb

• Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
• 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)

• 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
• Sign informed consent