Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery

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

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.

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.

Inclusion Criteria:

1. Institutional Review Board/ International Ethics Committee 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 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
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

Exclusion Criteria:

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, intraaortic balloon pumping (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
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