About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ㎡
Disqualifiers
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 within the previous 12 weeks: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class II or above heart failure, stroke, etc;
Within 12 weeks prior to the first medication, systemic use (excluding local and nasal inhalation use) of immunosuppressants, including but not limited to glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, Tripterygium wilfordii, etc; Have used an endothelin receptor antagonist within 12 weeks prior to the first medication;
Trial design
Single group
Treatments tested in this trial
"Nefecon®","Ambrisentan"
DrugSubjects who meet the screening criteria will be treated with Budesonide in combination with Ambrisentan. Budesonide (Nefecon®), 16mg/d for 36 weeks, taken orally. Ambrisentan , 5mg/d for 36 weeks, taken orally.
Treatment groups
Trial outcomes
Primary outcomes
Percent change in UPCR (24h urine)
Secondary outcomes
Change in eGFR
Changes in IgA/IgG/IgM and Gd-IgA1 levels at all visits
Annualized eGFR slope at Week 36
Sponsors and contacts
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