A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery

Inclusion criteria

• 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

Exclusion criteria

• 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