Chronic Kidney Disease Clinical Trial
Official title:
A Phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design)
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
Status | Recruiting |
Enrollment | 180 |
Est. completion date | April 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Eastern Theater Command | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shandong Suncadia Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to Week 13 in UACR | From Baseline to Week 13 | ||
Secondary | Change From Baseline to Week 13 in UACR category (>20%, >30%, >40%) | From Baseline to Week 13 | ||
Secondary | Change From Baseline to Week 4, Week 7 in UACR | From Baseline to Week 4, Week 7 | ||
Secondary | Change From Baseline to Week 13 in 24-hour urinary protein quantification | From Baseline to Week 13 | ||
Secondary | 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 | ||
Secondary | Change From Baseline to Week 13 in blood pressure | From Baseline to Week 13 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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