Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT05126303
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT05126303
Study Brief:
Protocol Section:
NCT05126303