NCT05126303终止2 期
A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
Guard Therapeutics AB29 个研究点 分布在 5 个国家目标入组 177 人开始时间: 2022年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 177
- 试验地点
- 29
- 主要终点
- Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
研究概览
简要总结
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.
详细描述
This is a Phase 2, randomized, double-blind, adaptive, parallel group clinical study that will evaluate RMC-035 compared to placebo in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Subjects are randomized in a 1:1 ratio.
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
- •Institutional Review Board/ International Ethics Committee approved Informed Consent obtained
- •Ability to understand and comply with the study requirements and able to provide written informed consent
- •Age ≥18 and <85 years
- •Estimated glomerular filtration rate (eGFR) is ≥30 mL/min/1.73 m2
- •Subject is scheduled for non-emergent coronary artery bypass grafting (CABG) surgery and/or valve surgery and/or ascending aorta aneurysm surgery with use of cardiopulmonary bypass (CPB), and AKI risk factors are present at screening
- •Female subject is not of child-bearing potential, or agreeing not to become pregnant
- •Female subject must not be breastfeeding
- •Female subject must not donate ova
- •Male subject and their female spouse/partner(s) who are of childbearing potential must be using a highly effective form of birth control
- •Male subjects must not donate sperm
- •Subject agrees not to participate in another interventional study
排除标准
- •Medical condition that makes the subject unsuitable for study participation
- •Scheduled for emergent surgeries (eg, aortic dissection)
- •Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries (eg, congenital heart defects)
- •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 within 24 hours prior to surgery
- •Requirement for defibrillator or permanent pacemaker, mechanical ventilation, intraaortic balloon pumping (IABP), LVAD, or other forms of mechanical circulatory support (MCS)
- •Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery
- •Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
- •Ongoing sepsis or an untreated diagnosed clinically significant infection (viral or bacterial)
- •Total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN)
- •History of solid organ transplantation
- •History of renal replacement therapy (RRT)
- •Medical condition which requires active immunosuppressive treatment
- •Severe allergic asthma
- •Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
- •Received an investigational medicinal product within the last 90 days (or within 5 half-lives of the investigational drug, whichever is longer)
- •Subject has a known allergy to RMC-035 or one of its constituents, or has previously received RMC-035
研究组 & 干预措施
RMC-035
Experimental
RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.
Dosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.
干预措施: RMC-035 (Drug)
Placebo
Placebo Comparator
Identical to RMC-035 arm except that the placebo contains no active ingredient.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
时间窗: 72 hours
Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition
次要结局
- Characteristics of ADA (Cross-reactivity)(90 days)
- Peak SCr Value(7 days)
- Major Adverse Kidney Event (MAKE) - Cystatin C(90 days)
- Major Adverse Kidney Event (MAKE) - SCr and Cystatin C(90 days)
- Change in Serum Cystatin C Values Over Time(90 days)
- Change in SCr Values Over Time(90 days)
- Area Under the Curve (AUC) of Serum Creatinine (SCr)(72 hours)
- Duration of AKI(90 days)
- Peak Cystatin C Value(7 days)
- AKI Within 7 Days(7 days)
- Persistence of AKI(7 days)
- Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR)(90 days)
- Pharmacokinetics of RMC-035 (AUC)(4 days)
- Pharmacokinetics of RMC-035 (Cmax)(7 days)
- Presence of Anti-drug Antibodies (ADA)(90 days)
- AUC of Cystatin C(72 hours)
- Number of Participants Requiring Renal Replacement Therapy (Dialysis)(7 days)
- Number of Days Without Need for Dialysis(90 days)
- Major Adverse Kidney Event (MAKE) - SCr(90 days)
- AKI Within 72 Hours Based on Cystatin C and UO(72 hours)
- Severity of AKI(7 days)
研究者
研究点 (29)
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