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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID

NCT05746559

Run by

Alexion Pharmaceuticals, Inc.

People needed

555

Starts

2023-04-06

Expected to finish

2026-05-07

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Research Site — Kawasaki-shi, Japan
• Research Site — Minatoku, Japan
• Research Site — Okayama, Japan
• Research Site — Sagamihara-shi, Japan
• Research Site — Suginami City, Japan
• Research Site — Urayasu, Japan
• Research Site — Groningen, Netherlands
• Research Site — Maastricht, Netherlands
• Research Site — Bielsko-Biala, Poland
• Research Site — Chrzanów, Poland
• Research Site — Lodz, Poland
• Research Site — Lodz, Poland
• Research Site — Poznan, Poland
• Research Site — Szczecin, Poland
• Research Site — Tychy, Poland
• Research Site — Anyang-si, South Korea
• Research Site — Busan, South Korea
• Research Site — Daegu, South Korea
• Research Site — Seongnam-si, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Kamakura-shi, Japan

Full record on ClinicalTrials.gov

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