Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Ch… (NCT05126303) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
Stopped: Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint
United States177 participantsStarted 2022-03-31
Plain-language summary
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.
Who can participate
Age range18 Years – 84 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
✕. 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