A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease

Prior treatment

• Had acute kidney injury or end-stage renal disease, received peritoneal dialysis, hemodialysis or kidney transplantation; or planned to undergo kidney transplantation or chronic renal replacement therapy during the study period.
• Receiving blood transfusion for anemia.
• Medication compliance \<80% or \>120%.
• Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
• Prior exposure to systemic immunosuppressive drugs.
• Recent use of strong CYP3A inhibitors or CYP3A inducers.
• Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
• Participation in any other clinical trial and receipt of an investigational product within 3 months.
• Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.

Other illness

• Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.
• Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
• History or diagnostic evidence of other secondary hypertension.
• Subjects with severe hepatobiliary diseases.
• Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).
• Poorly controlled diabetes mellitus.
• Had cardiovascular disease that precludes participation in the study or any electrocardiogram (ECG) abnormalities deemed by the investigator to substantially increase the subject's risk.
• History of adrenal insufficiency.
• History of solid organ or bone marrow transplantation.
• History of acute diabetic complications.
• Active malignancy or past medical history of malignant tumor.
• History of substance abuse or chronic alcohol abuse.
• Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.

Lab values

• Serum sodium \<135 mmol/L .

Other

• Morbid obesity.
• Recent use of traditional Chinese medicine (TCM) or proprietary Chinese preparations indicated for urinary protein reduction.
• Recent blood donation or major blood loss (\>400 mL), or clinically diagnosed hypovolemia.
• Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.

• Aged ≥18 years , regardless of gender.
• Diagnosed with chronic kidney disease (CKD)
• Urine albumin-creatinine ratio (UACR) of ≥300 mg/g and ≤5000 mg/g.
• Serum potassium≥ lower limit of normal (LLN) and ≤4.8 mmol/L.
• Receiving stable background concomitant medication at screening
• Mean seated office systolic blood pressure (msSBP) ≥120 mmHg.
• Morning serum cortisol \>3 μg/dL.
• Voluntarily participate in the trial and provide written informed consent.
• Agree to comply with trial contraception and reproductive restrictions.