Nefecon and Ambrisentan in IgA Nephropathy
Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g/24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels
| Condition(s) | IgA Nephropathy, Chronic Kidney Disease, Proteinuria |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g/24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels |
| Who can participate | Inclusion Criteria: * Diagnosed with IgA nephropathy by pathological biopsy within 4 years; * Age between 18 and 70 years old; * 0.5g/24h ≤ 24-hour urinary protein; * The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula satisfies: eGFR ≥ 30 mL/min/1.73 ㎡ Exclusion Criteria: * Exclude special pathological or clinical kidney disease types such as crescentic glomerulonephritis (pathological diagnosis\>50%), minimal change nephropathy with IgA deposition, etc; * Exclude secondary IgA nephropathy, including allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, and mixed connective tissue disease; * Select patients who have experienced any of the following cardiovascular events |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | The First Hospital of Jilin University |
| Locations | Changchun, Jilin, China |
| Start date | 2025-09-01 |
| NCT ID | NCT07030894 |
| Official listing | https://clinicaltrials.gov/study/NCT07030894 |