ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE (ARTEMIS)
Chronic Kidney Disease, CKD, Cardiac Disease
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, CKD, Cardiac Disease, cardiopulmonary bypass
Eligibility Criteria
Inclusion Criteria: Participant weighs ≥ 30 kg Planned non-emergent sternotomy with CPB procedure for the following surgeries: Multi-vessel CABG Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4) Exclusion Criteria: Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator. Single-vessel CABG without valve surgery is planned. Off-pump surgery is planned (eg, surgery without CPB). Recipient of a solid organ or bone marrow transplantation. Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization. History of unexplained, recurrent infection. Any use of KRT or presence of AKI within 30 days of randomization Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study. Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed History of or unresolved N meningitidis infection.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research Site
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Ravulizumab
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.