NCT07647133

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseAldosterone Synthase InhibitorRenin

Outcome Measures

Primary Outcomes (1)

  • The baseline change of UACR

    Change from baseline in UACR compared to placebo at Week 16

    at week 16

Study Arms (3)

Low-dose group

EXPERIMENTAL
Drug: SAL0140 Tablets

High-dose group

EXPERIMENTAL
Drug: SAL0140 Tablets

Placebo group

PLACEBO COMPARATOR
Drug: SAL0140 placebo

Interventions

SAL0140 TabletsDRUG

SAL0140 Tablets

Low-dose group
SAL0140 placeboDRUG

placebo

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.
  • 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.
  • 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.
  • Serum sodium \<135 mmol/L .
  • 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).
  • Receiving blood transfusion for anemia.
  • Poorly controlled diabetes mellitus.
  • Morbid obesity.
  • 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.
  • Medication compliance \<80% or \>120%.
  • History of acute diabetic complications.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhihong Liu, Master

CONTACT

025-80862013zhliunj@vip.163.com

Zhen Liang, PhD

CONTACT

13798304368sunylz@163.com

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

June 9, 2026

First Posted

June 15, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 8, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)