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

Launched by GUARD THERAPEUTICS AB · Nov 8, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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