HS-10390 compared with irbesartan in adults with chronic kidney disease
Tests HS-10390 against irbesartan in adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07555054, who can take part
Where in China
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07555054
- Record updated
- 28 April 2026
- Original description
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/gRead full original descriptionShow less
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: 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.
Exclusion: 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; A known or suspected allergy to the investigational medical drug or its components or excipients; 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.