Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease
Brief 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
Interventions
DRUGHS-10390
HS-10390
DRUGIrbesartan
Target dose of 300 mg daily
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | Frame: From baseline (Day 1) until Week 12 (Day 85) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12 | From baseline (Day 1) until Week 12 (Day 85) |
| Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit | From baseline (Day 1) at each visit |
| Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From screening until Follow-up visit (Day 98) |
Countries
China
Contacts
CONTACTWei Chen Professor, MD
Outcome results
None listed