ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

Alexion Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Chronic Kidney Disease; Cardiac Disease; CKD; Cardiopulmonary Bypass

Treatments: Drug: Placebo; Drug: Ravulizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05746559

2022-501802-36 (EudraCT Number)

ALXN1210-CSA-AKI-318 (Other Identifier)

D928DC00001

Details and patient eligibility

About

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.

Enrollment: 736 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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736 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.

Treatment:

Drug: Placebo

Ravulizumab

Experimental group

Description:

Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.

Treatment:

Drug: Ravulizumab