Early Initial Therapy, IgA Nephropathy (IgAN)
Conditions
Keywords
IgA Nephropathy (IgAN), Nefecon, multi-center, Early Initial Therapy
Brief summary
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
Interventions
OTHERGd-IgA1 test
collect and test Gd-IgA1 test in enrolled subjects
Sponsors
Sichuan Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Target patients aged 18-75, including those aged 18 and 75 2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months 3. eGFR≥30ml/min/1.73m2 4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g 5. Sign informed consent
Exclusion criteria
1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis 2. Patients who have received kidney transplantation or dialysis 3. 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) 4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections 5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%) 6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias 7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg) 8. Patients diagnosed with malignant tumors within the past 5 years 9. Patients with known glaucoma, known cataracts, and/or a history of cataract surgery 10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea 11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms 12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment 13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment 14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4) 15. Current or previous (within the past 2 years) alcoholism or drug abuse; 16. Expected lifespan\<5 years 17. 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) 18. Researchers believe that patients who are not suitable for treatment with Nefecon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. | about 12 months | Safety event |
| The changes in proteinuria levels | about 12 months | To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline | about 12 months |
| Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients | about 12 months |
| Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month | about 12 months |
| Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month | about 12 months |
| Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month | about 12 months |
| Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month | about 12 months |
| Evaluate the changes in eGFR of target patients at the 12th month compared to baseline | about 12 months |
Other
| Measure | Time frame |
|---|---|
| Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline. | about 12 months |
Countries
China
Contacts
Primary ContactGuisen Li, Doctor
Outcome results
None listed