2025-523037-25-00招募中2 期
A Phase 2, Multi-center, Randomized, Dose-Ranging, Placebo-Controlled, Double-blind Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated - Acute Kidney Injury.
River 2 Renal Corp.33 个研究点 分布在 2 个国家目标入组 440 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 33
- 主要终点
- Proportion of subjects developing AKI within 7 days after start of on-pump cardiac surgery based on SCr (AKI of any stage according to KDIGO criteria, see above)
研究概览
简要总结
To evaluate the safety and efficacy of R2R01 for prevention of AKI (KDIGO definition) after cardiac surgery (CABG, valve surgery, aortic surgery, or a combination of the above) involving CPB, in subjects with additional risk factors for developing CSA-AKI.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase 2,multi-center,randomized,dose-ranging,placebo-controlled,double-blind Study Of The Re
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF)
- •At least 18 years of age
- •Subject is scheduled for non-emergent CABG (single or multiple vessels), valve surgery (single or multiple valves), surgery of the ascending part of the aorta, or a combination of the above, involving cardiopulmonary bypass (CPB), AND risk factors for acute kidney injury (AKI) are present (at screening) as specified below: a. If only one type of surgery is scheduled, at least two AKI risk factors should be present b. If any combined surgery is scheduled, at least one AKI risk factor should be present. Risk factors for AKI: • Diabetes mellitus on pharmacological treatment • Confirmed diagnosis of hypertension • Documented history of Chronic Heart Failure with New York Heart Association (NYHA) class III or higher (see section 11.5 in Appendix) • Left ventricular ejection fraction (LVEF) ≤40% • Peripheral vascular disease defined as one or more of the following: claudication, carotid occlusion or >50% stenosis, amputation for arterial disease, previous or planned intervention on the abdominal aorta, limb arteries or carotids • Stroke/transient ischemic attack (TIA) defined as sudden onset of focal or global brain, spinal cord, or retinal vascular damage, resulting in symptoms and signs of acute nervous system defects, associated with cerebral circulation disorders • Documented atrial fibrillation (AF) on the ECG performed at the screening visit • Anemia with hemoglobin ≤11 g/dL at any time during the 3-month period before or at the time of screening • Body Mass Index (BMI) ≥ 30 kg/m2 • Age ≥70 years at the time of screening
- •Have stable renal function per Investigator assessment
- •Subject agrees not to participate in another interventional study after signing the ICF and until the end of study (EoS) visit has been completed
排除标准
- •Patient currently enrolled into another interventional clinical trial
- •Patient with a kidney transplant
- •Subject has a known or suspected glomerulonephritis at the time of randomization
- •Cardiogenic shock, hemodynamic instability, mechanical ventilation, intra-aortic balloon pump (IABP), left ventricular assist device (LVAD) or other forms of mechanical circulatory support (MCS), within 7 days prior to surgery
- •Patient received inotropes or vasopressors within 48 hours prior to the day of surgery
- •Known or suspected sepsis
- •Confirmed or suspected endocarditis
- •Other current active infection requiring antibiotic treatment
- •Patient has severe liver disease (Child-Pugh score >7 points)
- •Recently received (within the last 4 weeks) or is anticipated to receive before the end of the study chemotherapy which can interfere with kidney function (e.g. Platinum agents)
- •Patient previously enrolled and randomized into this study
- •Subject is scheduled for emergent surgery
- •Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestate, confirmed by a positive human chorionic gonadotropin laboratory
- •Known hypersensitivity to the study drug or any of its excipients
- •Any medical or social condition deemed by the investigator to be likely to interfere with a patient’s ability to give informed consent, cooperate, and participate in the study or to be likely to interfere with the interpretation of the results
- •Cardiac surgery planned to be performed "off-pump" without CPB
- •Expected CPB duration < 60 minutes
- •Body weight <50 kg; >120 kg
- •Presence of AKI (KDIGO criteria) at the time of randomization
- •Current, recent (within 4 weeks), or scheduled renal replacement therapy
- •Patients who are post-nephrectomy
- •Patients with CKD of equal or more than stage IV (GFR≤30 ml/min/1.73 m2)
研究组 & 干预措施
SODIO CLORURO BAXTER S.P.A. 0,9% Soluzione per infusione
Placebo
干预措施: SODIO CLORURO BAXTER S.P.A. 0,9% Soluzione per infusione (Drug)
结局指标
主要结局
Proportion of subjects developing AKI within 7 days after start of on-pump cardiac surgery based on SCr (AKI of any stage according to KDIGO criteria, see above)
Proportion of subjects developing AKI within 7 days after start of on-pump cardiac surgery based on SCr (AKI of any stage according to KDIGO criteria, see above)
Nature, frequency and severity of treatment-emergent adverse events (TEAEs).
Nature, frequency and severity of treatment-emergent adverse events (TEAEs).
次要结局
- Severity grade of AKI within 7 days after start of cardiac surgery based on SCr (according to KDIGO criteria, see above).
- Duration of AKI defined as the number of days meeting the definition of AKI (according to KDIGO criteria, see above).
- Change in SCr and cystatin C (and corresponding eGFR values) at postoperative hours 12, 24, 48, 72, and postoperative Days 7 and 30, versus baseline
- Proportion of subjects with a major adverse kidney event (MAKE) defined as all-cause mortality, RRT and/or ≥ 25% sustained reduction of kidney function (i.e., a reduction of eGFR of 25% or more compared to the baseline pre-surgery sample, using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equations (with either SCr, CyC, or both) at postoperative Day 7 and at postoperative Day 30
- Length of ICU stay (in hours) defined as the duration of stay in the ICU immediately following surgery (or recovery room post-surgery) until ICU discharge
- Length of Hospital stay (in days) defined as the duration of stay in the hospital from the day of surgery to hospital discharge
- ICU free days and hospital free days
- Proportion of subjects readmitted to the hospital at postoperative Day 30
研究者
Chief Medical Officer
Scientific
River 2 Renal Corp.
研究点 (33)
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