Starting soon
Phase 2
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
Condition(s) studied
Chronic Kidney Disease
Investigational drug(s) / intervention(s)
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
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)
- Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 — Frame: From baseline (Day 1) until Week 12 (Day 85)
Trial sites (1)
| Facility | City | Region | Status |
| The First Affiliated Hospital,Sun Yat-sen University |
Guangzhou |
Guangdong |
|
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