Phase
Condition
Nephritis
Nephropathy
Glomerulonephritis
Treatment
Placebo
Finerenone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgAnephropathy excluded;
Age ≥ 18 years;
Maximum tolerated dose of RAS inhibitors for more than 3 months, with urinealbumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showingurine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerateddose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;
eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;
Serum potassium level ≤ 4.8 mmol/L;
SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;
LVEF > 40%;
Willing and able to provide informed consent.
Exclusion
Exclusion Criteria:
There are clear indications for the use of immunosuppressive therapy, such as:nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30g/L), pathological minimal change disease combined with IgA nephropathy; theproportion of crescents in kidney biopsy is ≥ 50%.
Any existing life-threatening condition with a life expectancy of less than 2 years;
Active infection, HBV infection, or active lesions (nodules, cavities, ortuberculomas);
AKI causing renal dysfunction;
Use of steroids/immunosuppressive drugs within the past 3 months;
History of malignant tumors, regardless of treatment status or evidence of localrecurrence or metastasis;
Any surgical or medical condition that may significantly alter the absorption,distribution, metabolism, or excretion of the investigational drug;
History of drug or alcohol abuse within the past 12 months;
History of drug allergies or contraindications;
Previous noncompliance or unwillingness to follow the study protocol;
Any condition that may affect safety or efficacy;
History of kidney transplantation or currently receiving immunosuppressivetreatment;
Pregnant or breastfeeding women;
Obese patients with a BMI > 35.