NCT06475274已完成2 期
A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery
Guard Therapeutics AB6 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年8月26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
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)
研究概览
简要总结
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is:
- Does RMC-035 protect the function of kidneys after surgery?
- Is RMC-035 safe?
Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if
- Kidney function better for participants treated with any of the RMC-035 doses?
- What medical problems do participants have when receiving RMC-035?
Participants will
- Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery
- Have extra checkups and tests during their hospital stay
- Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eGFR ≥30 ml/min/1.73m2
- •Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery
- •Risk factors for acute kidney injury are present
- •Participant capable of providing written informed consent
- •Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm
排除标准
- •Any medical condition that makes the participant unsuitable
- •Scheduled for emergent surgeries
- •Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
- •Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
- •Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as intraaortic balloon pumping (IABP) within 24 hours prior to surgery
- •Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support.
- •Diagnosed with AKI prior to surgery
- •Requires cardiopulmonary resuscitation prior to surgery
- •Ongoing sepsis or an untreated diagnosed clinically significant infection
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN).
- •Total bilirubin ≥2.0 time ULN
- •History of solid organ transplantation
- •History of renal replacement therapy
- •Severe allergic asthma
- •Chronic immunosuppressive treatment that may have an impact on kidney function
- •Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
- •Current enrolment or past recent participation in any other clinical study involving an investigational study treatment
- •Previously treatment of RMC-035
- •Sensitivity to any of the study interventions, or components thereof
研究组 & 干预措施
RMC-035 high-dose
Experimental
RMC-035 60 mg
干预措施: RMC-035 (Drug)
RMC-035 low-dose
Experimental
RMC-035 30 mg
干预措施: RMC-035 (Drug)
Placebo
Placebo Comparator
Placebo (tris-buffer)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)
时间窗: 90 days
Difference in estimated glomerular filtration rate (eGFR) at Day 90 (end of study) compared to baseline.
次要结局
- Occurrence of MAKE (and each MAKE component) at Day 90(90 days)
研究者
研究点 (6)
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