ARTEMIS: Ravulizumab to Protect Patients with CKD from CSA-AKI and MAKE: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study

Participation Requirements

• Sex:

  Female, Male

• Eligible Ages:

  18 to 90

Participation Criteria

Inclusion Criteria:
1. ≥ 18 to ≤ 90 years of age at the time of signing the informed consent.
2. Male or female (female participants of childbearing potential and male participants must follow protocol-specified contraception guidance)
3. Body weight ≥ 30 kg at Screening.
4. 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
Note-surgery should be scheduled to occur within 35 days of screening (up to 28-day screening period with randomization and dosing within 1 to 7 days prior to CPB).
5. Known CKD (Stage 3A, 3B, or 4) for at least 3 months with eGFR ≥ 20 to < 60 mL/min/1.73m2, eGFR confirmed at screening (may be repeated once during screening) and randomization using CKD-EPI equation by sCr or sCycC measurement, obtained by local or central laboratory.
6. At risk for post-surgical AKI as defined by a minimum STS Calculator Renal Failure Risk Score of 3%.
7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
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 (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 LVAD 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 during course of study.
10. Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed.