NCT04564833已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 25
- 主要终点
- Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
研究概览
简要总结
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin [SnPP]/iron sucrose [FeS]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥18 years of age at Screening.
- •Able and willing to comply with all study procedures.
- •Stable kidney function per Investigator assessment and no known episodes of AKI during the preceding 4 weeks.
- •Scheduled to undergo non-emergent coronary and/or valve surgery(ies) requiring cardiopulmonary bypass, including:
- •CABG alone;
- •Combined CABG surgery/repair of 1 or more cardiac valves;
- •Cardiac valve(s) replacement or repair alone.
- •Females and males of childbearing potential must agree to use 2 forms of contraception, with at least 1 being a barrier method, or abstain from sexual activity for 30 days following study drug administration.
- •Male subjects must agree not to donate or sell sperm for 30 days following study drug administration.
排除标准
- •Presence of AKI (KDIGO criteria) at the time of Screening.
- •Surgery to be performed without cardiopulmonary bypass.
- •Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature <28°C (82.4°F).
- •eGFR ≤20 mL/min/1.73m2 or need for dialysis.
- •Surgery for aortic dissection or to correct a major congenital heart defect.
- •Administration of iodinated contrast media within 24 hours prior to cardiac surgery or evidence of contrast-induced nephropathy prior to cardiac surgery.
- •Cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery and requirement for inotropes or vasopressors or other mechanical devices, such as intra-aortic balloon counter-pulsation.
- •Requirement for any of the following within 7 days prior to cardiac surgery:
- •Defibrillator or permanent pacemaker;
- •Mechanical ventilation;
- •Intra-aortic balloon counter-pulsation;
- •Left ventricular assist device;
- •Other forms of mechanical circulatory support.
- •Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin.
- •Known or suspected sepsis at time of Screening or confirmed or treated endocarditis within 30 days prior to cardiac surgery.
- •Other current active infection requiring systemic antibiotic treatment.
- •Inadequate hepatic function, defined as total bilirubin or alanine aminotransferase or aspartate aminotransferase >2X the upper limit of normal at time of Screening or Child Pugh Class C liver disease or higher.
- •Any congenital coagulation disorder.
- •Asplenia (anatomic or functional).
- •History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-
- •Known hypersensitivity or previous anaphylaxis to SnPP or any tin-based product.
- •Serum ferritin >500 ng/mL or those who have received IV iron within 28 days of Screening.
- •Pregnancy or lactation.
- •Treatment with an investigational drug or participation in an interventional study within 30 days prior to administration of study drug.
- •In the opinion of the Investigator, any disease processes or confounding variables that would inappropriately alter the outcome of the study.
- •Inability to comply with the requirements of the study protocol.
研究组 & 干预措施
Low Dose RBT-1
Experimental
Single IV infusion prior to cardiac surgery
干预措施: Low Dose RBT-1 (Drug)
High Dose RBT-1
Experimental
Single IV infusion prior to cardiac surgery
干预措施: High Dose RBT-1 (Drug)
Placebo
Placebo Comparator
Single IV infusion prior to cardiac surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
时间窗: Baseline through Pre-Surgery
Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)
次要结局
- Change in Renal Tubular Injury Biomarkers(Baseline through Day 3 post-cardiac surgery)
- Number of Subjects With Reduction in Urine Output(Baseline through post-cardiac surgery through Day 5)
- Number of Subjects With Acute Kidney Injury (AKI)(Baseline through Day 5 post-cardiac surgery)
研究者
研究点 (25)
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