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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.
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

Full criteria on ClinicalTrials.gov

Sites (111)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-Buenos AiresArgentinaUnknown status
-Ciudad de Buenos AiresArgentinaUnknown status
-CorrientesArgentinaUnknown status
-Santa FeArgentinaUnknown status
-BrisbaneAustraliaUnknown status
-MonashAustraliaUnknown status
-MurdochAustraliaUnknown status
-SouthportAustraliaUnknown status
-Belo HorizonteBrazilUnknown status
-FortalezaBrazilUnknown status
-RecifeBrazilUnknown status
-Ribeirão PretoBrazilUnknown status
-Rio de JaneiroBrazilUnknown status
-SalvadorBrazilUnknown status
-São José do Rio PretoBrazilUnknown status
-São PauloBrazilUnknown status
-EdmontonCanadaUnknown status
-HamiltonCanadaUnknown status
-KingstonCanadaUnknown status
-MontrealCanadaUnknown status
-Saint JohnCanadaUnknown status
-TorontoCanadaUnknown status
-WinnipegCanadaUnknown status
-ShanghaiChinaUnknown status
-ShenzhenChinaUnknown status
-TianjinChinaUnknown status
-ZhengzhouChinaUnknown status
-Frankfurt am MainGermanyUnknown status
-GiessenGermanyUnknown status
-HalleGermanyUnknown status
-HeidelbergGermanyUnknown status
-JenaGermanyUnknown status
-MünchenGermanyUnknown status
-TrierGermanyUnknown status
-A CoruñaSpainUnknown status
-BarcelonaSpainUnknown status
-CórdobaSpainUnknown status
-MadridSpainUnknown status
-MajadahondaSpainUnknown status
-NavarraSpainUnknown status
-SevilleSpainUnknown status
-ValenciaSpainUnknown status
-ValladolidSpainUnknown status
-BordeauxFranceUnknown status
-DijonFranceUnknown status
-MontpellierFranceUnknown status
-ToulouseFranceUnknown status
-CambridgeUnited KingdomUnknown status
-ClydebankUnited KingdomUnknown status
-LondonUnited KingdomUnknown status
-Newcastle upon TyneUnited KingdomUnknown status
-Hong KongHong KongUnknown status
-HaifaIsraelUnknown status
-BangaloreIndiaUnknown status
-GūrgaonIndiaUnknown status
-HyderabadIndiaUnknown status
-MysuruIndiaUnknown status
-SecunderabadIndiaUnknown status
-BariItalyUnknown status
-FlorenceItalyUnknown status
-MilanItalyUnknown status
-NaplesItalyUnknown status
-Bunkyō CityJapanUnknown status
-ChūōkuJapanUnknown status
-Kamakura-shiJapanUnknown status
-Kawasaki-shiJapanUnknown status
-MinatokuJapanUnknown status
-OkayamaJapanUnknown status
-Sagamihara-shiJapanUnknown status
-Suginami CityJapanUnknown status
-UrayasuJapanUnknown status
-Anyang-siSouth KoreaUnknown status
-BusanSouth KoreaUnknown status
-DaeguSouth KoreaUnknown status
-Seongnam-siSouth KoreaUnknown status
-SeoulSouth KoreaUnknown status
-GroningenNetherlandsUnknown status
-MaastrichtNetherlandsUnknown status
-Bielsko-BialaPolandUnknown status
-ChrzanówPolandUnknown status
-LodzPolandUnknown status
-PoznanPolandUnknown status
-SzczecinPolandUnknown status
-TychyPolandUnknown status
-AnkaraTürkiyeUnknown status
-AntalyaTürkiyeUnknown status
-IstanbulTürkiyeUnknown status
-Menemen/IzmirTürkiyeUnknown status
-OdunpazariTürkiyeUnknown status
-Hualien CityTaiwanUnknown status
-Kaohsiung CityTaiwanUnknown status
-New Taipei CityTaiwanUnknown status
-TaichungTaiwanUnknown status
-TainanTaiwanUnknown status
-TaipeiTaiwanUnknown status
-BostonUnited StatesUnknown status
-CharlestonUnited StatesUnknown status
-CharlottesvilleUnited StatesUnknown status
-ChicagoUnited StatesUnknown status
-DallasUnited StatesUnknown status
-FargoUnited StatesUnknown status
-Kansas CityUnited StatesUnknown status
-OrangeUnited StatesUnknown status
-PhiladelphiaUnited StatesUnknown status
-RichmondUnited StatesUnknown status
-RochesterUnited StatesUnknown status
-San FranciscoUnited StatesUnknown status
-SeattleUnited StatesUnknown status
-SpringfieldUnited StatesUnknown status
-StanfordUnited StatesUnknown status
-ValhallaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.