NCT07419828招募中3 期
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
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 5,386 人开始时间: 2026年3月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,386
- 试验地点
- 1
- 主要终点
- Time to the first appearance of the composite endpoint:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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
研究组 & 干预措施
HRS-1780 tablets
Experimental
干预措施: HRS-1780 tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to the first appearance of the composite endpoint:
时间窗: month 60
* Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR \<15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or * CV Death.
The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months.
时间窗: month 32
次要结局
- The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.(month 60)
- The annualized total slope of eGFR from baseline to 36 months.(month 36)
- The ratio of UACR to baseline at the 6th month .(month 6)
- The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.(month 32)
- The ratio of UACR to the baseline.(month 32)
- The annualized slope of eGFR from 3 months after randomization to the end of treatment.(month 32)
研究者
研究点 (1)
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