The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy. The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.
This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy. Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study. The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio: * Finerenone 10mg/20 mg * Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
10mg or 20mg
10mg or 20mg
change in uACR between the two groups
Time frame: at 12months
eGFR slop
Time frame: at 12months
change in uPCR between the two groups
Time frame: at 12months
renal failure (eGFR decline of 40% or progression to ESKD, defined as initiation of dialysis, kidney transplantation, or eGFR ≤ 15 ml/min/1.73 m²);
Time frame: at 12months
cardiovascular event endpoints: cardiovascular death or non-fatal myocardial infarction or non-fatal stroke; hospitalization due to heart failure; major cardiovascular events; all-cause mortality.
Time frame: at 12months
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