Testing SAL0140 at different doses in people with chronic kidney disease

Trial details

Who runs it

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Trial code

NCT07647133

Record updated

15 June 2026

Original description

This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).Read full original descriptionShow less

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease

This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).

Inclusion: 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.

Exclusion: 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; 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; Serum sodium <135 mmol/L ; 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.

ClinicalTrials.gov NCT07647133