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;
Parallel
HRS-1780 tablets
DrugOral tablets
Placebo
DrugOral tablets
The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months.
The annualized slope of eGFR from 3 months after randomization to the end of treatment.
The ratio of UACR to the baseline.
The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.
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