🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07555054
Starting soon Phase 2

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

NCT07555054 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2026-05-21
Last updated
2026-04-28

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

HS-10390HS-10390HS-10390Irbesartan

HS-10390: HS-10390

HS-10390: HS-10390

HS-10390: HS-10390

Irbesartan: Target dose of 300 mg daily

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong

On this site

📄 Avapro (irbesartan) drug profile →

More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07555054 on ClinicalTrials.gov ↗ ← All trials in China