Chronic Kidney DiseasePhase 2NCT07716618
A Phase II Clinical Trial of the Safety and Efficacy of SAL0120 in Patients With Chronic Kidney Disease (CKD)
A Phase 2 study testing SAL0120 1mg, SAL0120 2mg and SAL0120 4mg in people with Chronic Kidney Disease, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- SAL0120 1mg, SAL0120 2mg and SAL0120 4mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 31 Aug 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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;
- Patients with malignant tumors (including hematological malignancies), except for the following circumstances: tumors determined to be cured or in remission for 5 years, basal cell or squamous cell carcinoma of the skin that has been radically removed, or carcinoma in situ at any location;
- Patients with severe hepatobiliary system diseases (for example, AST or ALT >2 times the upper limit of normal value at Screening Visit 1, or patients with liver cirrhosis, or total bilirubin >2 times the upper limit of normal value at Screening Visit 1);
- Have a history of alcohol or drug abuse within 1 year before screening. Alcohol abuse is defined as: drinking more than 14 units of alcohol per week (1 unit of alcohol = 360ml of beer or 45ml of spirits with an alcohol content of 40% or 150ml of wine);
- People with serious mental illness, including but not limited to: schizophrenia, bipolar disorder, depression, mania, etc.;
- Patients with active hepatitis B (if hepatitis B surface antigen is positive, HBV DNA testing is required. If hepatitis B surface antigen is positive and the HBV DNA test is >500 copies/mL or >100 IU/mL, patients with active hepatitis B must be excluded). Hepatitis C (if the HCV antibody test is positive, HCV RNA testing is required. If the HCV antibody test is positive and the HCV RNA result is positive, hepatitis C patients must be excluded); patients with active syphilis (if the Treponema pallidum antibody test is positive, antibody titer testing is required, and patients with active syphilis are excluded according to the center's testing standards); HIV-positive patients, whose condition is in a stable stage, can be included by the researcher based on the comprehensive performance of the subjects;
- Patients who are pregnant, lactating, or have the possibility of pregnancy (based on the pregnancy test results of screening visit 1, the researcher cannot rule out the possibility of pregnancy);
- Patients who have been treated with other experimental drugs (or investigational drugs) or treated with experimental medical devices (or research devices) within 3 months before screening and before randomization, or who are participating in interventional clinical research (a medical behavior that exceeds routine diagnosis and treatment, performed for research purposes) and receiving treatment;
- Any other medical condition that, in the opinion of the investigator, may pose a safety risk to the subjects in this study, may confound the evaluation of efficacy or safety, or may interfere with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of SAL0120 Tablets in Patients With Chronic Kidney Disease (CKD).
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
- Being tested
- SAL0120 1mg, SAL0120 2mg, SAL0120 4mg, Placebo
- Keywords
- Chronic kidney disease
- 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.
SAL0120 1mgDrug
SAL0120 1mg
SAL0120 2mgDrug
SAL0120 2mg
SAL0120 4mgDrug
SAL0120 4mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| SAL0120 1mg | Experimental | Not described Receives: Drug: SAL0120 1mg |
| SAL0120 2mg | Experimental | Not described Receives: Drug: SAL0120 2mg |
| SAL0120 4mg | Experimental | Not described Receives: Drug: SAL0120 4mg |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start17 Jan 2025
- Primary completion27 May 2026
- Study completion31 Aug 2026 (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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Salubris (Suzhou) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716618
- Sponsor's protocol ID
- SAL0120C201
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 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 Evaluating the Efficacy and Safety of SAL0120 Tablets in Patients With Chronic Kidney Disease (CKD).
- ClinicalTrials.gov ID
- NCT07716618
- Acronym / sponsor ID
- SAL0120C201
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Salubris (Suzhou) Pharmaceutical Co., Ltd.
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAL0120 1mg | Experimental | Drug: SAL0120 1mg |
| SAL0120 2mg | Experimental | Drug: SAL0120 2mg |
| SAL0120 4mg | Experimental | Drug: SAL0120 4mg |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (23 listed)
- 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.);
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 |
|---|---|---|
| SAL0120 1mgSAL0120 1mg | Drug | SAL0120 1mg |
| SAL0120 2mgSAL0120 2mg | Drug | SAL0120 2mg |
| SAL0120 4mgSAL0120 4mg | Drug | SAL0120 4mg |
| Placeboplacebo | Drug | placebo |
Primary outcome
The baseline relative change in UACR；The change from baseline in UACR across SAL0120 dose groups
Time frame: at 12 weeks
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.
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 21 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAL0120 1mg, SAL0120 2mg and SAL0120 4mg in people with Chronic Kidney Disease, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site 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 7 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline relative change in UACR；The change from baseline in UACR across SAL0120 dose groups (time frame: at 12 weeks). 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 21 Jul 2026.