Evidence map›Paper›PMID 40448185›Full record

ArticleTrials2025

A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS).

Marlies Ostermann, David C Corteville, Kent Doi, Jay L Koyner, Andre Lamy, Gerry Li, Christine M Solinsky, Pamela D Winterberg, William T Smith, Ravindra L Mehta and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05746559 (ARTEMIS), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05746559 phase3terminatednot on this map

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

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2023 to 2026Enrolled555ConditionsChronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary BypassArmsPlacebo, Ravulizumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Risk factors for postoperative acute kidney injury after cardiac surgery.Archivos peruanos de cardiologia y cirugia cardiovascular
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Marlies OstermannCritical Care and Nephrology, NHS Foundation Trust, Guy's and St Thomas, London, UK.
David C CortevilleDepartment of Cardiology, Rochester Regional Health, Rochester, USA.
Kent DoiEmergency and Critical Care Medicine, The University of Tokyo Hospital, Tokyo, Japan.
Jay L KoynerSection of Nephrology, The University of Chicago, Chicago, USA.
Andre LamyDivision of Cardiac Surgery and Population Health Research Institute, McMaster University, Hamilton, Canada.
Gerry LiAlexion, AstraZeneca Rare Disease, Boston, USA.
Christine M SolinskyAlexion, AstraZeneca Rare Disease, Boston, USA. christine.solinsky@alexion.com.
Pamela D WinterbergAlexion, AstraZeneca Rare Disease, Boston, USA.
William T SmithAlexion, AstraZeneca Rare Disease, Boston, USA.
Ravindra L MehtaDepartment of Medicine, San Diego School of Medicine, University of California, San Diego, USA.
Patrick T MurrayUniversity College Dublin Clinical Research Centre, UCD School of Medicine, Dublin, Ireland.
Andrew D ShawDepartment of Intensive Care and Resuscitation, Cleveland Clinic, Cleveland, USA.
Alexander ZarbockDepartment of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Münster, Germany.
Daniel T EngelmanHeart & Vascular Program Baystate Health, University of Massachusetts Chan Medical School-Baystate, Springfield, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiac procedures, particularly those requiring cardiopulmonary bypass (CPB), are associated with the development of cardiac surgery-associated acute kidney injury (CSA-AKI). Development of CSA-AKI occurs as a result of inflammation, uncontrolled complement activation, and kidney cell damage. In patients with preoperative renal impairment, such as those with chronic kidney disease (CKD), there is an increased risk of both CSA-AKI and poorer clinical outcomes. Currently, there are limited effective, targeted pharmacological interventions for the prevention or treatment of CSA-AKI, although emerging therapies are being investigated, particularly in patients with existing CKD. The ARTEMIS (RAvulizumab to PRotect PaTients with Chronic Kidney DisEase froM CSA-AKI and Subsequent Major Adverse Kidney Events) trial will assess the efficacy and safety of ravulizumab (a complement C5 inhibitor) in reducing the risk of major adverse kidney events (MAKE) in patients with preoperative CKD undergoing non-emergent cardiac surgery with CPB.

methodsThis trial is currently recruiting patients with CKD who have planned cardiac surgery requiring CPB including coronary artery bypass grafting, valve replacement or repair, or combined procedures. This is a phase 3, randomized, double-blind, placebo-controlled, global study assessing the efficacy and safety of a single preoperative dose of ravulizumab. These outcomes will be assessed using the occurrence of MAKE and its components, as well as the occurrence and severity of CSA-AKI throughout the study period. DISCUSSION: Complement activation is known to occur during and after cardiac procedures as a result of CPB and ischemia-reperfusion injury, leading to a cycle of cell damage and death. Therefore, it is hypothesized that preoperative administration of ravulizumab will provide immediate and complete complement inhibition, which will be sustained throughout the surgical period, preventing the uncontrolled complement activation associated with the development of CSA-AKI, thus minimizing poor outcomes for patients.

trial registrationClinicalTrials.gov NCT05746559. Registered on February 27, 2023.

Indexed as

Acute Kidney InjuryAntibodies, Monoclonal, HumanizedCardiac Surgical ProceduresComplement Inactivating AgentsRenal Insufficiency, ChronicCardiopulmonary BypassClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, Monoclonal, HumanizedComplement Inactivating AgentsCardiac surgery-associated acute kidney injuryCardiopulmonary bypassChronic kidney diseaseComplement activationInterventional studyIschemia–reperfusion injuryRavulizumab

Identifiers

PMID40448185
PMCPMC12125780

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.