EUCTR2021-004040-19-DE进行中（未招募）1 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 - AKITA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 268
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. IRB/IEC approved Informed Consent obtained
- •2. Ability to understand and comply with the study requirements and able
- •to provide written informed consent
- •3. Age =18 and <85 years
- •4. Estimated glomerular filtration rate (eGFR) is =30 mL/min/1.73 m2
- •5. Subject is scheduled for non-emergent CABG surgery and/or valve
- •surgery and/or ascending aorta aneurysm surgery with use of CPB, and
- •AKI risk factors are present at screening
- •6. Female subject is not of child-bearing potential, or agreeing not to
- •become pregnant
- •7. Female subject must not be breastfeeding
- •8. Female subject must not donate ova
- •9. Male subject and their female spouse/partner(s) who are of childbearing
- •potential must be using a highly effective form of birth control
- •10. Male subjects must not donate sperm
- •11. Subject agrees not to participate in another interventional study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1. Medical condition that makes the subject unsuitable for study
- •participation
- •2. Scheduled for emergent surgeries (eg, aortic dissection)
- •3. Scheduled for CABG and/or valve surgery and/or ascending aorta
- •aneurysm surgery combined with additional non-emergent cardiac
- •surgeries (eg, congenital heart defects)
- •4. 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
- •5. Experiences a cardiogenic shock or hemodynamic instability which
- •require inotropes or vasopressors or other mechanical devices within 24 hours prior to surgery
- •6. Requirement for defibrillator or permanent pacemaker, mechanical
- •ventilation, IABP, LVAD, or other forms of mechanical circulatory support (MCS)
- •7. Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery
- •8. Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
- •9. Ongoing sepsis or an untreated diagnosed clinically significant infection (viral or bacterial)
- •10. Total bilirubin or alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) = 2 times the upper limit of normal (ULN)
- •11. History of solid organ transplantation
- •12. History of renal replacement therapy (RRT)
- •13. Medical condition which requires active immunosuppressive treatment
- •14. severe allergic asthma defined as confirmed diagnosis of asthma poorly controlled while receiving high-dose inhaled corticosteroid treatment, or with requirement of a high level of treatment to maintain control
- •15. Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
- •16. Received an investigational medicinal product within the last 90 days (or within 5 half-lives of the investigational drug, whichever is longer)
- •17. Subject has a known allergy to RMC-035 or one of its constituents, or has previously received RMC-035
研究者
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