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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: SAL0140 Tablets; Drug: SAL0140 placebo

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of multiple doses of SAL0140 in patients with chronic kidney disease (CKD). 249 participants diagnosed with chronic kidney disease will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy).

The study will consist of the following 4 periods: screening period, run-in period, double-blind treatment period and follow-up period. Patients will complete the study in approximately 8 months.

• Study Type: Interventional
• Enrollment (Estimated): 249
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhihong Liu, Master; Phone Number: 025-80862013; Email: zhliunj@vip.163.com
• Study Contact Backup: Name: Zhen Liang, PhD; Phone Number: 13798304368; Email: sunylz@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
      • Contact: Zhen Liang, PhD; Phone Number: 13798304368; Email: sunylz@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
      • Contact: Zhihong Liu, Master; Phone Number: 025-80862013; Email: zhliunj@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.
2. 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.
3. 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.
4. History or diagnostic evidence of other secondary hypertension.
5. Serum sodium <135 mmol/L .
6. Subjects with severe hepatobiliary diseases.
7. Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).
8. Receiving blood transfusion for anemia.
9. Poorly controlled diabetes mellitus.
10. Morbid obesity.
11. 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.
12. History of adrenal insufficiency.
13. History of solid organ or bone marrow transplantation.
14. Medication compliance <80% or >120%.
15. History of acute diabetic complications.
16. Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
17. Prior exposure to systemic immunosuppressive drugs.
18. Recent use of traditional Chinese medicine (TCM) or proprietary Chinese preparations indicated for urinary protein reduction.
19. Recent use of strong CYP3A inhibitors or CYP3A inducers.
20. Active malignancy or past medical history of malignant tumor.
21. Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
22. History of substance abuse or chronic alcohol abuse.
23. Recent blood donation or major blood loss (>400 mL), or clinically diagnosed hypovolemia.
24. Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.
25. Participation in any other clinical trial and receipt of an investigational product within 3 months.
26. Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.
27. Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: SAL0140 placebo; placebo
Experimental: Low-dose group	Drug: SAL0140 Tablets; SAL0140 Tablets
Experimental: High-dose group	Drug: SAL0140 Tablets; SAL0140 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The baseline change of UACR	Change from baseline in UACR compared to placebo at Week 16	at week 16

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 8, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Renin; Aldosterone Synthase Inhibitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: SAL0140B201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No