Chronic Kidney DiseasePhase 2NCT07647133
A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease
A Phase 2 study testing SAL0140 Tablets in people with Chronic Kidney Disease, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- SAL0140 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
- Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
- Prior exposure to systemic immunosuppressive drugs.
- Recent use of traditional Chinese medicine (TCM) or proprietary Chinese preparations indicated for urinary protein reduction.
- Recent use of strong CYP3A inhibitors or CYP3A inducers.
- Active malignancy or past medical history of malignant tumor.
- Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
- History of substance abuse or chronic alcohol abuse.
- 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.
- 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.
- Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210002
Zhihong Liu, Master, 025-80862013, zhliunj@vip.163.com
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen Liang, PhD, 13798304368, sunylz@163.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- SAL0140 Tablets, SAL0140 placebo
- Keywords
- Chronic Kidney Disease, Aldosterone Synthase Inhibitor, Renin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0140 TabletsDrug
SAL0140 Tablets
SAL0140 TabletsDrug
SAL0140 Tablets
SAL0140 placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Drug: SAL0140 Tablets |
| High-dose group | Experimental | Not described Receives: Drug: SAL0140 Tablets |
| Placebo group | Placebo comparator | Not described Receives: Drug: SAL0140 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline change of UACR
Change from baseline in UACR compared to placebo at Week 16
Measured: at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion8 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647133
- Sponsor's protocol ID
- SAL0140B201
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07647133
- Acronym / sponsor ID
- SAL0140B201
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Aldosterone Synthase Inhibitor, Renin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: SAL0140 Tablets |
| High-dose group | Experimental | Drug: SAL0140 Tablets |
| Placebo group | Placebo comparator | Drug: SAL0140 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL0140 TabletsSAL0140 Tablets | Drug | Low-dose group |
| SAL0140 TabletsSAL0140 Tablets | Drug | High-dose group |
| SAL0140 placeboplacebo | Drug | Placebo group |
Primary outcome
The baseline change of UACR
Time frame: at week 16
Change from baseline in UACR compared to placebo at Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAL0140 Tablets in people with Chronic Kidney Disease, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu, Master (025-80862013, zhliunj@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline change of UACR (time frame: at week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.