CKD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins the study and signs the informed consent; 2. Aged 18 to 80 years (based on the date of signing the informed consent), with no gender limitation; Body mass index (BMI) >= 25 kg/m2; 4. Estimated glomerular filtration rate (eGFR) >= 45 mL/min/1.73m2; 5. Urinary microalbumin creatinine ratio (UACR) 30-3000 mg/g; 6. HbA1c < 9% with systolic blood pressure (SBP) <= 140 MMG and diastolic blood pressure (DBP) <= 90 MMG; 7. Have not used angiotensin converting enzyme inhibitors/angiotensin ? receptor blockers or sodium-glucose cotransporter 2 inhibitors; 8. Female and male subjects of reproductive age, and male subjects' partners agree to use effective contraceptive methods (such as abstinence, physical or hormonal contraception, etc.) throughout the treatment period and for 6 months after the treatment period; 9. The subject will communicate well with the investigator and be able to follow the study requirements for visits, treatment, laboratory tests, and other related requirements.
Exclusion criteria
Exclusion criteria: 1. Persons with a history of allergy or allergic constitution (such as allergy to pollen, two or more drugs/food, or to angiotensin converting enzyme inhibitors/angiotensin ? receptor blockers and sodium-glucose cotransporter 2 inhibitors or their excipients); 2. Patients with autosomal dominant polycystic kidney disease (ADPKD), systemic lupus erythematosus (SLE), antineutrophil cytoplasmic antibody (ANCA) related vasculitis, acute nephritis, obstructive nephropathy, history of renal artery stenosis, nephrotic syndrome; 3. History of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis (DKA); 4. Those who are using or are expected to require hormone or immunosuppressant therapy > 20 mg/d within 6 months; 5. Urine microalbumin creatinine ratio (UACR) or estimated glomerular filtration rate (eGFR) increased by more than 100% or decreased by more than 50% during screening period; 6. Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism and excretion; 7. Patients with diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of nervous system, cardiovascular system, blood and lymphatic system, immune system, liver, gastrointestinal system, respiratory system and bone system, and a history of tumor; 8. Patients with previous amputation, peripheral vascular and neuropathy, and diabetic foot ulcers; 9. Patients with abnormal vital signs, physical examination, electrocardiogram and laboratory examination results that are clinically significant and considered unsuitable for inclusion by the researcher; 10. Patients with venous blood collection difficulty, needle-sickness, tablet swallowing difficulty or any history of gastrointestinal diseases affecting drug absorption; 11. Screening for those with a history of drug abuse in the previous 6 months; 12. Participated in any drug clinical trial and took the study drug within 3 months prior to this trial (the last visit time of the last trial was calculated as the start time); 13. Women who are pregnant or breast-feeding or who have a positive pregnancy test before the test; 14. Patients with mental disorders, depression, anxiety and other patients with poor treatment compliance; 15. Other conditions that the investigator determines are unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine microalbumin-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate;BMI;blood pressure;waistline;uric acid; | — |
Countries
China
Contacts
Beijing Hospital