A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAL0140 Tablets, SAL0140 Tablets, SAL0140 placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SAL0140 Tablets
SAL0140 Tablets - Drug SAL0140 Tablets
SAL0140 Tablets - Drug SAL0140 placebo
placebo
Primary outcome measures
- The baseline change of UACR [Time frame: at week 16]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University Shenzhen Hospital — Shenzhen
- Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing
Identifiers
NCT: NCT07647133 · SAL0140B201