NCT06632613招募中2 期
A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass
EnnovaBio1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AE) and serious adverse events (SAE)
研究概览
简要总结
The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and comply with the study requirements and able to provide written informed consent;
- •Age ≥18 and ≤85 years;
- •Male subjects (and their fertile female spouses/partners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. Only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: Postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an FSH >30 IU/L in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \ bilateral tubal resection and/or bilateral ovariectomy.
- •Subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: Coronary artery bypass grafting (CABG) and/or heart valve surgery and/or aortic root, ascending aorta and aortic arch surgery;
- •Subjects have the risk of developing AKI with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for AKI; Multiple heart valves surgery plus at least one AKI risk factor; Coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for AKI; Coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for AKI.
排除标准
- •Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;
- •Cardiopulmonary resuscitation is performed within 14 days prior to screening;
- •Abnormal renal function with eGFR<20 mL/min/1.73 m2 within 30 days before screening;
- •Receive renal replacement therapy or the presence of AKI within 30 days before surgery, except for transient (≤5 days) stage 1 AKI after iodized contrast agent exposure;
- •Participate in other clinical trials within the past 1 month;
- •Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;
- •Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.
研究组 & 干预措施
ENN0403 capsules, low dose
Experimental
干预措施: ENN0403 capsules, low dose (Drug)
ENN0403 capsules, high dose
Experimental
干预措施: ENN0403 capsules, high dose (Drug)
Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AE) and serious adverse events (SAE)
时间窗: 30 days
Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition
时间窗: 5 days
次要结局
- Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine per KDIGO definition(5 days)
- Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition(3 days, 7 days)
- Major Adverse Kidney Event (MAKE) at Day 30(Day 30)
- Length of stay in the intensive care unit (ICU) and hospital(30 days)
研究者
研究点 (1)
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