A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease

A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease

The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g

Inclusion Criteria:

1. Men and women aged 18-70 years old;
2. Body mass index (BMI) ≥18.0 and <50.0 kg/m^2 at screening;
3. Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
4. Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m^2 calculated using the 2021 CKD-EPI creatine formula at screening;
5. Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
6. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
7. Agree to contraception.

Exclusion Criteria:

1. A known or suspected allergy to the investigational medical drug or its components or excipients;
2. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
3. If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
4. Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
5. Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
6. Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
7. Acute kidney injury or dialysis treatment within 6 months before screening;
8. Received kidney transplant, or plan to receive kidney transplant during the trial;
9. Platelet< 100×10^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
10. Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
11. Serum potassium >5.5 mmol/L at screening.