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

• Status: Not yet recruiting
• Trial end date: 2025-02-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Ravulizumab

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 (Stage 3A, 3B, or 4) for at least 3 months

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.