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

Korábbi kezelés

• Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
• If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
• Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
• Acute kidney injury or dialysis treatment within 6 months before screening;
• Received kidney transplant, or plan to receive kidney transplant during the trial;

Más betegség

• A known or suspected allergy to the investigational medical drug or its components or excipients;

Laborértékek

• Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
• Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
• Platelet< 100×10\^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
• 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;
• Serum potassium >5.5 mmol/L at screening.

• Men and women aged 18-70 years old;
• Body mass index (BMI) ≥18.0 and <50.0 kg/m\^2 at screening;
• 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;
• 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;
• 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;
• Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
• Agree to contraception.