A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease

Официальное название

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase III Study Evaluating the Efficacy and Safety of HRS-1780 in Adult Participants With Chronic Kidney Disease

Обзор

The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.

Вмешательства

• Препарат HRS-1780 tablets
  Oral tablets
• Препарат Placebo
  Oral tablets

Первичные конечные точки

• Time to the first appearance of the composite endpoint: [Срок оценки: month 60]

Вторичные конечные точки (3)

• The annualized total slope of eGFR from baseline to 36 months. [Срок оценки: month 36]
• The ratio of UACR to baseline at the 6th month . [Срок оценки: month 6]
• The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment. [Срок оценки: month 60]

Критерии участия

Критерии включения

• Male or female, aged ≥18 and <80 years old on the day of signing the informed consent form;
• a) The estimated glomerular filtration rate calculated by the CKD-EPI 2009 formula of the Chronic Kidney Disease Epidemiology Collaboration was eGFR≥60 and <90 mL/min/1.73 m2, and UACR≥300 mg/g; Or b) eGFR≥30 and <60 mL/min/1.73 m2, and UACR≥30 mg/g ; Or c) eGFR≥25 and <30 mL/min/1.73 m2；
• Serum potassium ≤4.8 mmol/L
• HbA1c was less than 10.5%.

Критерии исключения

• Uncontrolled severe hypertension at the time of screening or randomization (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• Alanine aminotransferase (ALT) >3× upper limit of normal (ULN); Aspartate aminotransferase (AST) >3×ULN; Total bilirubin >2.0×ULN;
• Diagnosis or suspicion of polycystic kidney disease, anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis;

Acute kidney injury occurred within 90 days before screening or hemodialysis or peritoneal dialysis treatment was received;

• Have received a kidney transplant in the past or plan to receive a kidney transplant during the trial period;
• There are diseases that may cause hyperkalemia during screening or randomization (such as Addison's disease);
• Within 180 days prior to the screening, the participants had the following diseases of clinical significance, which, as determined by the investigators, might interfere with the trial results or pose additional risks to the administration of the study drug: including but not limited to respiratory system, digestive system, cardiovascular and cerebrovascular, endocrine, immune, urinary, adrenal, blood, nervous, mental and other diseases;
• Stroke, transient ischemic attack, myocardial infarction, coronary revascularization, and decompensated heart failure (NYHA grade III-IV) occurred within 90 days before screening. And/or planned to undergo coronary, carotid or peripheral artery revascularization at the time of screening

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 · 1 центр

• National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospita — Нанкин

Идентификаторы

NCT: NCT07419828 · HRS-1780-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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