Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shandong Suncadia Medicine Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
