replication of the nefigard trial of trf-budesonide in primary igan

Conditions: Primary IgA Nephropathy

Summary: this replication of the nefigard trial of trf-budesonide aims to use real-world data to evaluate the efficiency and safety of trf-budesonide in the treatment of iga nephropathy, from completing real-world research to providing real-world evidence.

currently, trf-budesonide are the first specific treatment for iga nephropathy that targets intestinal mucosal immunity. results from part a of the phase iii clinical trial (nct03643965) show that compared to the placebo group, the trf-budesonide group significantly reduced proteinuria and hematuria, stabilized renal function, and lowered circulating gd-iga1 levels at 12 months. however, further real-world studies are needed to verify the efficiency and safety of this treatment for iga nephropathy. therefore, this replication trial of the part a of the phase iii clinical trial nefigard and evaluates the efficiency and safety of trf-budesonide in treating iga nephropathy based on existing observational data, aiming to complete real-world research to provide real-world evidence that can guide clinical practice for iga nephropathy treatment.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥18 years; 2. primary iga nephropathy confirmed by renal biopsy; 3. stable use of ras blockers; 4. 24-hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol); 5. egfr ≥30 ml/min/1.73m². exclusion criteria: 1. systemic diseases that may cause interstitial iga deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis; 2. patients who have received kidney transplants; 3. those with other glomerular diseases (such as c3 glomerular disease or diabetic nephropathy) and nephrotic syndrome; 4. patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (tb), human immunodeficiency virus (hiv), and chronic urinary tract infections; 5. patients with cirrhosis or severe liver function impairment, as assessed by the investigator; 6. patients diagnosed with poorly controlled type 1 or type 2 diabetes; 7. patients with a history of unstable angina, grade iii or iv congestive heart failure, and/or arrhythmia as assessed by the investigator; 8. patients with poorly controlled blood pressure with systolic or diastolic blood pressure ≥140mmhg or 90mmhg. at least one blood pressure measurement should be in the above range (based on up to three measurements, 1 minute apart, taken after resting in the supine position for at least 5 minutes); 9. patients diagnosed with malignancy within the last 5 years, with the exception of treated basal cell carcinoma of the skin, curably resected squamous cell carcinoma of the skin, polyps of the colon, or carcinoma in situ of the cervix; 10. patients with osteoporosis who are known to be at moderate or high risk. chinese patients are defined according to the asian osteoporosis self-assessment tool (osta) index; 11. patients with known glaucoma, known history of cataract and/or cataract surgery that may interfere with study drug action or release (such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea); 12. patients who are allergic to budesonide or any component of the investigational drug formulation; 13. patients who have previously had a severe adverse reaction to steroids; 14. patients with psychotic symptoms; 15. have received any systemic glucocorticoid therapy within 3 months prior to medication; 16. received immunosuppressants or biologics within 3 months prior to medication; 17. patients taking potent inhibitors of the cytochrome p450 3a4 enzyme (cyp3a4); 18. current or former (within the last 2 years) alcohol or drug abuse; 19. patients who are unwilling or unable to meet program requirements; 20. life expectancy \<5 years; 21. women who are pregnant, nursing, or unwilling to use contraception during treatment.