Chronic Kidney Disease
Conditions
Brief summary
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13
Interventions
DRUGHRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo
Drug：HRS-1780 tablet Drug：Henagliflozin Proline tablet Drug：HRS-1780 tablet placebo Drug：Henagliflozin Proline tablet placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women aged 18-75 years old 2. Body mass index (BMI) ≥18.0 and \<50.0 kg/m2 at the screening visit 3. Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks 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 m2 calculated using the CKD-EPI formula at the screening visit 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 the screening visit 6. HbA1c \<9.0% at the screening visit
Exclusion criteria
1. A known or suspected allergy to the investigational drug or its components or excipients; 2. Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening; 3. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs, endothelin receptor antagonists; 4. Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening 5. Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening 6. Received systemic glucocorticoid therapy within 3 months before screening 7. Received immunosuppressive drugs or biological agents 8. Received any other study drug treatment within 3 months or 5 half-lives prior to screening 9. Severe hypertension that was not controlled at screening visit or random visit (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), or systolic blood pressure \<90 mmHg 10. Have urinary tract infection or/and genital infection at the screening visit or random visit, or have a history of repeated urinary tract infection or/and genital infection 11. Diagnosed or suspected polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis; 12. Acute kidney injury or dialysis treatment within 6 months before screening 13. Received kidney transplant, or plan to receive kidney transplant during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 13 in UACR | From Baseline to Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 13 in 24-hour urinary protein quantification | From Baseline to Week 13 |
| Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%) | From Baseline to Week 13 |
| Change From Baseline to Week 4, Week 7 in UACR | From Baseline to Week 4, Week 7 |
| Change From Baseline to Week 13 in estimated glomerular filtration rate (eGFR). An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. | From Baseline to Week 13 |
| Change From Baseline to Week 13 in blood pressure | From Baseline to Week 13 |
Countries
China
Outcome results
None listed