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Using Ravulizumab to Protect Kidney Patients During Heart Surgery

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

PHASE3 · Alexion Pharmaceuticals, Inc. · NCT05746559

This study is testing if a single dose of ravulizumab can help protect kidney patients from serious kidney problems during heart surgery.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment736 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorAlexion Pharmaceuticals, Inc. (industry)
Drugs / interventionsravulizumab
Locations215 sites (Tucson, Arizona and 214 other locations)
Trial IDNCT05746559 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a single intravenous dose of ravulizumab compared to a placebo in reducing the risk of acute kidney injury (AKI) and its clinical consequences in adults with chronic kidney disease (CKD) undergoing non-emergent cardiac surgery with cardiopulmonary bypass (CPB). Participants must have a known history of CKD and are scheduled for specific cardiac procedures. The study aims to assess outcomes at 90 days post-surgery to determine the potential protective effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic kidney disease who are scheduled for non-emergent cardiac surgeries involving cardiopulmonary bypass.

Not a fit: Patients requiring emergency cardiac surgery or those undergoing off-pump procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of kidney complications in patients with CKD undergoing heart surgery.

How similar studies have performed: Previous studies have shown promising results with similar interventions in protecting kidney function during cardiac procedures, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tucson, Arizona and 214 other locations

+165 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.