NCT05746559TerminatedPhase 3
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 555 (actual)
- First submitted
- 16 Feb 2023
- Start date
- 6 Apr 2023
- Primary completion date
- 7 Oct 2025
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT05746559
- EudraCT number
- 2022-501802-36
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to 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
Other illness
- Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator.
- History of unexplained, recurrent infection.
- History of or unresolved N meningitidis infection.
Other
- Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
- Any use of KRT or presence of AKI within 30 days of randomization
Who the study is looking for
- 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)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (111)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Buenos Aires | Argentina | Unknown status |
| - | Ciudad de Buenos Aires | Argentina | Unknown status |
| - | Corrientes | Argentina | Unknown status |
| - | Santa Fe | Argentina | Unknown status |
| - | Brisbane | Australia | Unknown status |
| - | Monash | Australia | Unknown status |
| - | Murdoch | Australia | Unknown status |
| - | Southport | Australia | Unknown status |
| - | Belo Horizonte | Brazil | Unknown status |
| - | Fortaleza | Brazil | Unknown status |
| - | Recife | Brazil | Unknown status |
| - | Ribeirão Preto | Brazil | Unknown status |
| - | Rio de Janeiro | Brazil | Unknown status |
| - | Salvador | Brazil | Unknown status |
| - | São José do Rio Preto | Brazil | Unknown status |
| - | São Paulo | Brazil | Unknown status |
| - | Edmonton | Canada | Unknown status |
| - | Hamilton | Canada | Unknown status |
| - | Kingston | Canada | Unknown status |
| - | Montreal | Canada | Unknown status |
| - | Saint John | Canada | Unknown status |
| - | Toronto | Canada | Unknown status |
| - | Winnipeg | Canada | Unknown status |
| - | Shanghai | China | Unknown status |
| - | Shenzhen | China | Unknown status |
| - | Tianjin | China | Unknown status |
| - | Zhengzhou | China | Unknown status |
| - | Frankfurt am Main | Germany | Unknown status |
| - | Giessen | Germany | Unknown status |
| - | Halle | Germany | Unknown status |
| - | Heidelberg | Germany | Unknown status |
| - | Jena | Germany | Unknown status |
| - | München | Germany | Unknown status |
| - | Trier | Germany | Unknown status |
| - | A Coruña | Spain | Unknown status |
| - | Barcelona | Spain | Unknown status |
| - | Córdoba | Spain | Unknown status |
| - | Madrid | Spain | Unknown status |
| - | Majadahonda | Spain | Unknown status |
| - | Navarra | Spain | Unknown status |
| - | Seville | Spain | Unknown status |
| - | Valencia | Spain | Unknown status |
| - | Valladolid | Spain | Unknown status |
| - | Bordeaux | France | Unknown status |
| - | Dijon | France | Unknown status |
| - | Montpellier | France | Unknown status |
| - | Toulouse | France | Unknown status |
| - | Cambridge | United Kingdom | Unknown status |
| - | Clydebank | United Kingdom | Unknown status |
| - | London | United Kingdom | Unknown status |
| - | Newcastle upon Tyne | United Kingdom | Unknown status |
| - | Hong Kong | Hong Kong | Unknown status |
| - | Haifa | Israel | Unknown status |
| - | Bangalore | India | Unknown status |
| - | Gūrgaon | India | Unknown status |
| - | Hyderabad | India | Unknown status |
| - | Mysuru | India | Unknown status |
| - | Secunderabad | India | Unknown status |
| - | Bari | Italy | Unknown status |
| - | Florence | Italy | Unknown status |
| - | Milan | Italy | Unknown status |
| - | Naples | Italy | Unknown status |
| - | Bunkyō City | Japan | Unknown status |
| - | Chūōku | Japan | Unknown status |
| - | Kamakura-shi | Japan | Unknown status |
| - | Kawasaki-shi | Japan | Unknown status |
| - | Minatoku | Japan | Unknown status |
| - | Okayama | Japan | Unknown status |
| - | Sagamihara-shi | Japan | Unknown status |
| - | Suginami City | Japan | Unknown status |
| - | Urayasu | Japan | Unknown status |
| - | Anyang-si | South Korea | Unknown status |
| - | Busan | South Korea | Unknown status |
| - | Daegu | South Korea | Unknown status |
| - | Seongnam-si | South Korea | Unknown status |
| - | Seoul | South Korea | Unknown status |
| - | Groningen | Netherlands | Unknown status |
| - | Maastricht | Netherlands | Unknown status |
| - | Bielsko-Biala | Poland | Unknown status |
| - | Chrzanów | Poland | Unknown status |
| - | Lodz | Poland | Unknown status |
| - | Poznan | Poland | Unknown status |
| - | Szczecin | Poland | Unknown status |
| - | Tychy | Poland | Unknown status |
| - | Ankara | Türkiye | Unknown status |
| - | Antalya | Türkiye | Unknown status |
| - | Istanbul | Türkiye | Unknown status |
| - | Menemen/Izmir | Türkiye | Unknown status |
| - | Odunpazari | Türkiye | Unknown status |
| - | Hualien City | Taiwan | Unknown status |
| - | Kaohsiung City | Taiwan | Unknown status |
| - | New Taipei City | Taiwan | Unknown status |
| - | Taichung | Taiwan | Unknown status |
| - | Tainan | Taiwan | Unknown status |
| - | Taipei | Taiwan | Unknown status |
| - | Boston | United States | Unknown status |
| - | Charleston | United States | Unknown status |
| - | Charlottesville | United States | Unknown status |
| - | Chicago | United States | Unknown status |
| - | Dallas | United States | Unknown status |
| - | Fargo | United States | Unknown status |
| - | Kansas City | United States | Unknown status |
| - | Orange | United States | Unknown status |
| - | Philadelphia | United States | Unknown status |
| - | Richmond | United States | Unknown status |
| - | Rochester | United States | Unknown status |
| - | San Francisco | United States | Unknown status |
| - | Seattle | United States | Unknown status |
| - | Springfield | United States | Unknown status |
| - | Stanford | United States | Unknown status |
| - | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.