ARTEMIS: A Phase 3 Study of Ravulizumab to Protect Patients with CKD from CSA-AKI and MAKE

Official Title

ARTEMIS RAvulizumab to PRotect PaTients with Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study

Details

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

You can join if...

Inclusion Criteria:

1. Participant weighs greater than or equal to 30 kg
2. Planned non-emergent sternotomy with CPB procedure for the following surgeries:
3. Multi-vessel CABG
4. Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
5. Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
6. Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)

Exclusion Criteria:

1. Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator.
2. Single-vessel CABG without valve surgery is planned.
3. Off-pump surgery is planned (eg, surgery without CPB).
4. Recipient of a solid organ or bone marrow transplantation.
5. Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
6. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
7. History of unexplained, recurrent infection.
8. Any use of KRT or presence of AKI within 30 days of randomization
9. 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.
10. Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
11. History of or unresolved N meningitidis infection.