The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.
0.4 mg/kg per day (maximum, 32 mg/day) for 2 months followed by dose tapering by 4 mg per day each month (total duration 6-9 months
Methylprednisolone 1g intravenous on day +1
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Time frame: 12 months
Change in proteinuria >50%
This is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Time frame: 12 months
Change in eGFR (using 2021 CKD-EPI Formula)
• Change in eGFR (using 2021 CKD-EPI Formula) at 6 and 12 months compared to baseline
Time frame: 6 months, 12 months
Change in hematuria from Baseline to 12 month visit.
Hematuria is measured in the urinalysis done at baseline and 12-month visit.
Time frame: 12 months
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Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)