Primary IgA Nephropathy
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGTARPEYO 4 MG Delayed Release Oral Capsule
TARPEYO dispensing claim for any dose is exposure
DRUGRAS inhibitor
RASi dispensing claim for any dose is reference
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint | 9 months | Assessment of the change in 24-hour urine protein levels from baseline after 9 months of follow-up. |
| Change in eGFR from Baseline at 9 Months | 9 months | Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 9 months of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-Hour Urine Protein Levels Compared to Baseline at 12 Months | 12 months | Assessment of the change in 24-hour urine protein levels from baseline after 12 months of follow-up. |
| Change in eGFR Compared to Baseline at 12 Months | 12 months | Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 12 months of follow-up. |
| Incidence Rate of Adverse Events | 12 months | Calculation of the incidence rate of adverse events during the study period. |
Countries
China
Outcome results
None listed