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

Chronic Kidney Disease Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746559
• Other study ID #: D928DC00001
• Secondary ID: ALXN1210-CSA-AKI
• Status: Recruiting
• Phase: Phase 3
• Start date: April 6, 2023
• Est. completion date: May 17, 2026

Study information

• Verified date: May 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: Alexion Pharmaceuticals, Inc. (Sponsor)
• Phone: 1-855-752-2356
• Email: clinicaltrials[@]alexion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 736
• Est. completion date: May 17, 2026
• Est. primary completion date: May 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiopulmonary Bypass
• Chronic Kidney Disease
• CKD
• Heart Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
• Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad Autónoma de Bs. As.
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Corrientes
Argentina	Research Site	San Luis
Argentina	Research Site	Santa Fé
Australia	Research Site	Brisbane
Australia	Research Site	Canberra
Australia	Research Site	Heidelberg
Australia	Research Site	Monash
Australia	Research Site	Murdoch
Australia	Research Site	Southport
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Campinas
Brazil	Research Site	Fortaleza
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Ribeirão Preto
Brazil	Research Site	S.J. Do Rio Preto
Brazil	Research Site	Salvador
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montréal	Quebec
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Toronto	Ontario
China	Research Site	Fuzhou
China	Research Site	Gaozhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Ningbo
China	Research Site	Shanghai
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Tianjin
China	Research Site	Wuhan
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Giessen
Germany	Research Site	Halle (Saale)
Germany	Research Site	Heidelberg
Germany	Research Site	Jena
Germany	Research Site	Muenster
Germany	Research Site	München
Germany	Research Site	Trier
Hong Kong	Research Site	Hong Kong
India	Research Site	Bangalore
India	Research Site	Bangalore
India	Research Site	Delhi
India	Research Site	Gurgaon
India	Research Site	Hyderabad
India	Research Site	Mysuru
India	Research Site	Secunderabad
Israel	Research Site	Haifa
Israel	Research Site	Haifa
Israel	Research Site	Petah Tikva
Israel	Research Site	Ramat Gan
Italy	Research Site	Bari
Italy	Research Site	Milan
Italy	Research Site	Milano
Italy	Research Site	Napoli
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Kamakura-shi
Japan	Research Site	Kawasaki-shi
Japan	Research Site	Minato-ku
Japan	Research Site	Okayama-shi
Japan	Research Site	Sagamihara-shi
Japan	Research Site	Suginami
Japan	Research Site	Urayasu
Korea, Republic of	Research Site	Anyang-si
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Netherlands	Research Site	Groningen
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Rotterdam
Poland	Research Site	Bielsko-Biala
Poland	Research Site	Chrzanów
Poland	Research Site	Grudziadz
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Lódz
Poland	Research Site	Poznan
Poland	Research Site	Szczecin
Poland	Research Site	Tychy
Poland	Research Site	Warszawa
Spain	Research Site	A Coruna
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Córdoba
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda
Spain	Research Site	Navarra
Spain	Research Site	Santander
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Taiwan	Research Site	Hualien City
Taiwan	Research Site	New Taipei
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei City
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Clydebank
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Newcastle upon Tyne
United States	Research Site	Aurora	Colorado
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Gainesville	Florida
United States	Research Site	Haddon Heights	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Louisville	Kentucky
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Francisco	California
United States	Research Site	San Francisco	California
United States	Research Site	Seattle	Washington
United States	Research Site	Springfield	Massachusetts
United States	Research Site	Stanford	California
United States	Research Site	Tacoma	Washington
United States	Research Site	Tucson	Arizona
United States	Research Site	Valhalla	New York
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wisconsin Rapids	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Germany,  Hong Kong,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)		Day 90 post-CPB
Secondary	Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB		Day 90 post-CPB
Secondary	Number of Participants Free From Severe CSA-AKI (Kidney Disease: Improving Global Outcomes [KDIGO] Stage 2 or 3) Based on Highest Observed Serum Creatinine (sCr) Within 7 Days Post CPB		Baseline through Day 7 post-CPB
Secondary	Number of Participants Free From Any Severe Acute Kidney Injury (AKI) (Risk, Injury, Failure, Loss of Kidney Function, and End-Stage Kidney Disease [RIFLE] Injury or Failure Criteria) Based on Highest Observed sCr Within Day 30 Post CPB		Baseline through Day 30 post-CPB
Secondary	Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB		Baseline through Day 30 post-CPB
Secondary	Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB		Baseline through Day 30 post-CPB
Secondary	Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB		Days 30, 60, and 90 post-CPB
Secondary	Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB		Days 30, 60, and 90 post-CPB
Secondary	Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB		Baseline through Day 3 and Day 7 post-CPB
Secondary	Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB		Days 15, 30, and 60 post-CPB
Secondary	Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB		Days 3, 7, 15, 30, 60, and 90 post-CPB
Secondary	Number of Participants with AKI Progression on Days 15, 30, 60, and 90 Post CPB for Those Experiencing CSA-AKI Within 7 Days Post CPB		Days 15, 30, 60, and 90 post-CPB