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≥60 and <90 mL/min/1.73 m2, and UACR≥300 mg/g; Or b) eGFR≥30 and <60 mL/min/1.73 m2, and UACR≥30 mg/g ; Or c) eGFR≥25 and <30 mL/min/1.73 m2；
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 ≥180 mmHg and/or diastolic blood pressure ≥110 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;
Have received a kidney transplant in the past or plan to receive a kidney transplant during the trial period;
Parallel
HRS-1780 tablets
DrugOral tablets
Placebo
DrugOral tablets
Time to the first appearance of the composite endpoint:
* Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR \<15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or * CV Death.
The annualized total slope of eGFR from baseline to 36 months.
The ratio of UACR to baseline at the 6th month .
The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.
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