A Phase II Clinical Trial of the Safety and Efficacy of SAL0120 in Patients With Chronic Kidney Disease (CKD)

NCT07716618 | Active Not Recruiting Phase 2

• 1 other identifier: SAL0120C201
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial designed to investigate the efficacy and safety of different doses of sal0120 tablets in patients with CKD.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• The baseline relative change in UACR；The change from baseline in UACR across SAL0120 dose groups

  At 12 weeks of treatment, the changes in UACR (urinary albumin/creatinine ratio) relative to baseline were compared in each group; the differences in the changes in UACR relative to baseline among different dose groups of SAL0120 tablets were assessed.

  at 12 weeks

Study Arms (4)

SAL0120 1mg

EXPERIMENTAL

Drug: SAL0120 1mg

SAL0120 2mg

EXPERIMENTAL

Drug: SAL0120 2mg

SAL0120 4mg

EXPERIMENTAL

Drug: SAL0120 4mg

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAL0120 2mg DRUG

SAL0120 2mg

SAL0120 2mg

SAL0120 4mg DRUG

SAL0120 4mg

SAL0120 4mg

Placebo DRUG

placebo

placebo

SAL0120 1mg DRUG

SAL0120 1mg

SAL0120 1mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On the day of signing the informed consent, the age is 18-75 years old (including the boundary value), regardless of gender;
• at a stable dose within 12 weeks before screening;
• During screening, the patient is diagnosed with chronic kidney disease, and the estimated glomerular filtration rate eGFR calculated based on the CKD-EPI formula (see Appendix 1 for details) is ≥20 mL/min/1.73 m2;
• At screening visit 1, the urine albumin/creatinine ratio (UACR) measured twice on different days within ≤7 days must meet ≥300 and \<5000 mg/g at the same time;
• Body mass index (BMI) ≤40 kg/m2;
• All male subjects and female subjects of childbearing potential agree to use highly effective contraceptive methods 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).
• Be able to understand the procedures and methods of this study, and be willing to strictly abide by the clinical trial protocol and complete this trial.

You may not qualify if:

• Patients suspected or diagnosed with polycystic kidney disease (autosomal dominant and recessive), rapidly progressive glomerulonephritis; patients with acute kidney injury or receiving peritoneal dialysis or hemodialysis treatment within 6 months before the screening period;
• Known history of heart failure or disease related to fluid overload (such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites).
• Cardiovascular diseases that are not suitable for participation in the study: ① Primary heart valve disease, severe mitral/tricuspid regurgitation; patients planning to undergo heart valve repair or replacement; ② Patients with stroke, myocardial infarction, cerebral infarction (except asymptomatic cerebral infarction), and transient ischemic attack within 6 months before screening; ③ Carotid artery surgery or carotid artery angioplasty within 3 months before screening. ④Acute coronary syndrome (ACS)-related events within 3 months before screening; ⑤Congenital QT prolongation syndrome, history of other drug-related QT interval prolongation, prolongation of QT interval on electrocardiogram at screening visit 1 or at randomization (visit 2) (male QTcF\>470 ms; female QTcF\>480 ms); ⑥ The electrocardiogram results at screening visit 1 show clinically significant abnormalities, such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second or third degree atrioventricular block, etc.;
• Have used systemic steroid glucocorticoids or immunosuppressants within 3 months before screening, excluding topical or intra-articular, intranasal and inhaled glucocorticoids; have used rituximab and cytotoxic drugs within 6 months before screening;
• Have received strong inhibitors or inducers of P-gp within 2 weeks before screening (for example: ranolazine, verapamil, itraconazole, clarithromycin, quinidine, ritonavir, tipranavir, saquinavir, etc.); have received strong inhibitors or inducers of CYP3A within 2 weeks before screening (for example: rifampicin, phenytoin, carbamazepine, ketoconazole, etc.);
• Concomitant with the following clinically significant, unstable or uncontrolled diseases within 6 months before screening, including but not limited to respiratory system, digestive system, cardiovascular and cerebrovascular, endocrine, immune, urinary, adrenal, blood, neurological, psychiatric and other diseases or other medical diseases that may confuse the research results and bring additional risks to the subjects.
• Acute complications of diabetes such as diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis, and hypoglycemic coma occurred within 6 months before the screening period; and there were complications requiring acute treatment at screening visit 1, including but not limited to: proliferative vitreoretinopathy, maculopathy, painful diabetic peripheral neuropathy, and diabetic foot (ulcer, infection);
• Patients with poorly controlled hypertension (for example, screening visit 1 and random blood pressure show systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), or systolic blood pressure \<90mmHg;
• Nt-proBNP ≥ 600pg/mL at screening visit 1;
• Glycated hemoglobin (HbA1c) ≥9% at screening visit 1;
• Patients with type 1 diabetes;
• Hemoglobin \<90g/L at screening visit 1, or a history of blood transfusion to treat anemia within 3 months of screening.
• Have a history of pulmonary hypertension (WHO group 1), idiopathic pulmonary fibrosis or any lung disease requiring oxygen therapy (for example: chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.);
• Patients with a history of organ transplantation (except patients with a history of corneal transplantation) or patients who plan to have a kidney transplant during the study period;
• Known or suspected allergy to the study drug or its components or excipients;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead
• Salubris (Suzhou) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: January 17, 2025
• Primary Completion: May 27, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

CN (1)