Chronic kidney disease
Conditions
Interventions
Test Group 1:1 tablet SAL0120 tablets (1mg/tablet) + 3 tablets SAL0120 placebo (1mg/tablet)
Test Group 2:2 tablets SAL0120 tablets (1mg/tablet) + 2 tablets SAL0120 placebo (1mg/tablet)
Test Group 3:4 tablets SAL0120 tablets (1mg/tablet)
Control group:4 tablets SAL0120 placebo (1mg/tablet)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. On the day of signing the informed consent, the age is 18-75 years old (including the boundary value), male or female 2. Within 12 weeks prior to screening, are taking ACE inhibitors/ARBs and are on stable treatment with ACE inhibitors/ARBs at the maximum recommended dose or maximum tolerated dose for at least 4 weeks; On the basis of ACE inhibitors/ARBs, patients who have been taking a stable dose of SGLT2 for 12 weeks prior to screening can also be enrolled; 3. At screening, diagnosed with chronic kidney disease, the estimated glomerular filtration rate calculated based on the CKD-EPI formula (see Appendix 1 for details) eGFR >=20 mL/min/1.73 m2; 4. At screening visit 1, the urine albumin/creatinine ratio (UACR) measured twice in =300 and <5000mg/g at the same time; 5. Body mass index (BMI) <=40 kg/m2; 6. All male subjects and female subjects of childbearing potential agree to use a highly effective contraceptive method for contraception from the date of signing the ICF until 1 month after the last dose of the investigational drug (see Appendix 2 for details). 7. Able to understand the procedures and methods of this study, and willing to strictly abide by the clinical trial protocol to complete this trial.
Exclusion criteria
Exclusion criteria: 1. Patients suspected or diagnosed with polycystic kidney disease (autosomal dominant and recessive), rapidly progressive glomerulonephritis; Acute kidney injury or treatment on peritoneal dialysis or hemodialysis within 6 months prior to screening; 2. Known history of heart failure or conditions related to fluid overload (such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites). 3. Cardiovascular diseases that are not suitable for participating in the study: primary heart valve disease, severe mitral valve/tricuspid regurgitation; Patients who are scheduled for heart valve repair or replacement; Patients with stroke, myocardial infarction, cerebral infarction (except for silent cerebral infarction), transient ischemic attack within 6 months before screening; Carotid artery surgery or carotid artery angioplasty within 3 months prior to screening. Acute coronary syndrome (ACS)-related events within 3 months prior to screening; Congenital QT interval prolongation syndrome, history of QT interval prolongation associated with other drugs, ECG QT interval prolongation at screening visit 1 or at randomization (visit 2) (QTcF in males> 470 ms; female QTcF >480 ms); Clinically significant abnormalities were shown by electrocardiogram results at screening visit 1, such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.; 4. Use of systemic steroids, glucocorticoids or immunosuppressants within 3 months prior to screening, except topical or intra-articular, intranasal and inhaled glucocorticoids; Rituximab and cytotoxic drugs within 6 months prior to screening; 5. Have received inhibitors or inducers of P-gp (e.g., ranolazine, verapamil, itraconazole, clarithromycin, quinidine, ritonavir, tipranavir, saquinavir, etc.) within 2 weeks before screening; Have received inhibitors or inducers of CYP3A (e.g., rifampicin, phenytoin, carbamazepine, ketoconazole, etc.) within 2 weeks prior to screening; 6. Clinically significant, unstable or uncontrolled diseases within 6 months prior to screening, including but not limited to respiratory, digestive, cardiovascular and cerebrovascular, endocrine, immunologic, urinary, adrenal, hematological, neurological, psychiatric and other diseases or other medical diseases that may confuse the results of the study and bring additional risks to the subjects. 7. Acute complications of diabetes mellitus with diabetic ketoacidosis, hyperosmolar non-ketotic diabetic coma, lactic acidosis and hypoglycemic coma within 6 months before the screening period; and have complications requiring acute treatment at screening visit 1, including but not limited to: proliferative vitreoretinopathy, macular degeneration, painful diabetic peripheral neuropathy, diabetic foot (ulcer, infection); 8. Patients with poorly controlled hypertension (e.g., Screening Visit 1 and randomized blood pressure showing systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg), or systolic blood pressure =600pg/mL at Screening Visit 1; 10. Glycosylated hemoglobin (HbA1c) at screening visit 1 >=9%; 11.1 patients with type 1 diabetes; 12. Hemoglobin < 90g/L at screening visit 1, or a history of blood transfusion for anemia within 3 months of screening. 13. History of pulmonary arterial hypertension (WHO Group 1), idiopathic pulmonary fibrosis, or any lung disease requiring oxygen therapy (e.g.: chronic obstructive pulmo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin/creatinine ratio;Urine albumin/creatinine ratio;Sitting systolic blood pressure and seated diastolic blood pressure;Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine albumin/creatinine ratio;Proportion of patients with a decrease from baseline =30%, =40%, =50% in UACR;Proportion of patients with UACR less than 300mg/g;Change from baseline in UPCR (urine protein/creatinine ratio).;eGFR;Nt-proBNP;Incidence of adverse events related to fluid retention;Active metabolites; | — |
Countries
China
Contacts
Public ContactFu Ping
West China Hospital, Sichuan University
Outcome results
None listed