A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат SAL0140 Tablets
  SAL0140 Tablets
• Препарат SAL0140 Tablets
  SAL0140 Tablets
• Препарат SAL0140 placebo
  placebo

Первичные конечные точки

• The baseline change of UACR [Срок оценки: at week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University Shenzhen Hospital — Шэньчжэнь
• Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Нанкин

Идентификаторы

NCT: NCT07647133 · SAL0140B201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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