The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.
Male or female, aged ≥18 and <80 years old on the day of signing the informed consent form;
a) The estimated glomerular filtration rate calculated by the CKD-EPI 2009 formula of the Chronic Kidney Disease Epidemiology Collaboration was eGFR≥25 and <90 mL/min/1.73 m2, and UACR≥500 mg/g and ≤5000 mg/g; Or b) eGFR≥25 and <60 mL/min/1.73 m2, and UACR≥200 mg/g and <500 mg/g;
Serum potassium ≤4.8 mmol/L
HbA1c was less than 10.5%.
Uncontrolled severe hypertension at the time of screening or randomization (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure <90 mmHg;
Alanine aminotransferase (ALT) >3× upper limit of normal (ULN); Aspartate aminotransferase (AST) >3×ULN; Total bilirubin >2.0×ULN;
Diagnosis or suspicion of polycystic kidney disease, anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis;
Acute kidney injury occurred within 90 days before screening or hemodialysis or peritoneal dialysis treatment was received;