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New drug SAL0140 aims to slow kidney disease in major trial

NCT ID NCT07647133

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether the drug SAL0140 can reduce protein in the urine, a sign of kidney damage, in 249 adults with chronic kidney disease. Participants will receive either SAL0140 or a placebo for 16 weeks. The goal is to see if the drug can help control the disease and protect kidney function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAL0140
What this could lead to
If successful, this could point toward a new treatment to slow kidney damage in chronic kidney disease patients.
What could go wrong
This is an early Phase 2 trial, so results may not confirm benefit. The drug could have side effects or fail to outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 249 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

    Nanjing, Jiangsu, 210002, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

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