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

July 21, 2026 updated by: Alexion Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1180AAV
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1428
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1199ABB
        • Research Site
      • Corrientes, Argentina, W3400AMZ
        • Research Site
      • Santa Fe, Argentina, S3000EOM
        • Research Site
  • Australia
      • Brisbane, Australia, 4102
        • Research Site
      • Monash, Australia
        • Research Site
      • Murdoch, Australia, 6150
        • Research Site
      • Southport, Australia, 4215
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Research Site
      • Fortaleza, Brazil, 60430-375
        • Research Site
      • Recife, Brazil, 50070-550
        • Research Site
      • Ribeirão Preto, Brazil, 14051-140
        • Research Site
      • Rio de Janeiro, Brazil, 22270-005
        • Research Site
      • Salvador, Brazil, 40301-155
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil, 01323-900
        • Research Site
      • São Paulo, Brazil, 05403-000
        • Research Site
      • São Paulo, Brazil, 04012-180
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L4
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Research Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H2X 0C1
        • Research Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Research Site
  • China
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200080
        • Research Site
      • Shenzhen, China, 518036
        • Research Site
      • Shenzhen, China, 518053
        • Research Site
      • Tianjin, China, 300050
        • Research Site
      • Zhengzhou, China, 450052
        • Research Site
      • Zhengzhou, China, 450007
        • Research Site
  • France
      • Bordeaux, France, 33074
        • Research Site
      • Dijon, France, 21079
        • Research Site
      • Montpellier, France, 34000
        • Research Site
      • Toulouse, France, 31076
        • Research Site
  • Germany
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Giessen, Germany, 35392
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Jena, Germany, 07747
        • Research Site
      • München, Germany, 81377
        • Research Site
      • Trier, Germany, 54292
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Research Site
  • India
      • Bangalore, India, 560092
        • Research Site
      • Bangalore, India, 560069
        • Research Site
      • Gurgaon, India, 122001
        • Research Site
      • Hyderabad, India, 500 034
        • Research Site
      • Mysuru, India, 570004
        • Research Site
      • Secunderabad, India, 500003
        • Research Site
  • Israel
      • Haifa, Israel, 34362
        • Research Site
      • Haifa, Israel, 3109601
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Milan, Italy, 20138
        • Research Site
      • Naples, Italy, 80131
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Research Site
      • Chūōku, Japan, 104-8560
        • Research Site
      • Kamakura-shi, Japan, 247-8533
        • Research Site
      • Kawasaki-shi, Japan, 216-8511
        • Research Site
      • Minatoku, Japan, 105-8470
        • Research Site
      • Okayama, Japan, 700-0804
        • Research Site
      • Sagamihara-shi, Japan, 252-0375
        • Research Site
      • Suginami City, Japan, 168-0065
        • Research Site
      • Urayasu, Japan, 279-0001
        • Research Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Research Site
      • Maastricht, Netherlands, 6229 HX
        • Research Site
  • Poland
      • Bielsko-Biala, Poland, 43-316
        • Research Site
      • Chrzanów, Poland, 32-500
        • Research Site
      • Lodz, Poland, 91-347
        • Research Site
      • Lodz, Poland, 92-213
        • Research Site
      • Poznan, Poland, 60-355
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
      • Tychy, Poland, 43-100
        • Research Site
  • South Korea
      • Anyang-si, South Korea, 14068
        • Research Site
      • Busan, South Korea, 49241
        • Research Site
      • Daegu, South Korea, 42601
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Research Site
      • Seoul, South Korea, 02841
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 08308
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 120-752
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 8035
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Majadahonda, Spain, 28250
        • Research Site
      • Navarra, Spain, 31190
        • Research Site
      • Seville, Spain, 41071
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
      • Valladolid, Spain, 47003
        • Research Site
  • Taiwan
      • Hualien City, Taiwan, 970473
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • New Taipei City, Taiwan, 220
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11696
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Research Site
      • Antalya, Turkey (Türkiye), 07100
        • Research Site
      • Istanbul, Turkey (Türkiye), 34303
        • Research Site
      • Istanbul, Turkey (Türkiye), 34846
        • Research Site
      • Menemen/Izmir, Turkey (Türkiye), 35665
        • Research Site
      • Odunpazari, Turkey (Türkiye), 26080
        • Research Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Research Site
      • Clydebank, United Kingdom, G81 4DY
        • Research Site
      • London, United Kingdom, W12 0HS
        • Research Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Research Site
  • United States
    • California
      • Orange, California, United States, 92868
        • Research Site
      • San Francisco, California, United States, 94143
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Springfield, Massachusetts, United States, 01107
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • New York
      • Rochester, New York, United States, 14621
        • Research Site
      • Valhalla, New York, United States, 10595
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Research Site
      • Richmond, Virginia, United States, 23298
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
Drug: Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Experimental: Ravulizumab
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
Drug: Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
Time Frame: Day 90 post-CPB
Day 90 post-CPB

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB
Time Frame: Day 90 post CPB
  1. Occurrence of CSA-AKI without recovery at Day 90 post CPB
  2. Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB
  3. Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB
  4. Occurrence of KRT or death from randomization to Day 90 post CPB
  5. All-cause mortality from randomization to Day 90 post CPB
  6. Length of post-operative ICU stay
Day 90 post CPB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Investigators

  • Study Director: Tolga Baykal, MD, PhD, +34-609-454-477

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2023

Primary Completion (Actual)

October 7, 2025

Study Completion (Actual)

May 7, 2026

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D928DC00001
  • ALXN1210-CSA-AKI-318 (Other Identifier: Alexion Pharmaceuticals, Inc.)
  • 2022-501802-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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