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

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ClinicalTrials.gov Identifier: NCT05746559
Recruitment Status : Recruiting
First Posted : February 27, 2023
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease CKD Cardiac Disease Cardiopulmonary Bypass Drug: Placebo Drug: Ravulizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 6, 2023
Estimated Primary Completion Date : February 27, 2025
Estimated Study Completion Date : February 27, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ravulizumab

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
 Drug: Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Experimental: Ravulizumab
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
 Drug: Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB) [ Time Frame: Day 90 post-CPB ]

Secondary Outcome Measures :
  1. Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB [ Time Frame: Day 90 post-CPB ]
  2. 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 [ Time Frame: Baseline through Day 7 post-CPB ]
  3. 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 [ Time Frame: Baseline through Day 30 post-CPB ]
  4. Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB [ Time Frame: Baseline through Day 30 post-CPB ]
  5. Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB [ Time Frame: Baseline through Day 30 post-CPB ]
  6. Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB [ Time Frame: Days 30, 60, and 90 post-CPB ]
  7. Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB [ Time Frame: Days 30, 60, and 90 post-CPB ]
  8. Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB [ Time Frame: Baseline through Day 3 and Day 7 post-CPB ]
  9. Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB [ Time Frame: Days 15, 30, and 60 post-CPB ]
  10. Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB [ Time Frame: Days 3, 7, 15, 30, 60, and 90 post-CPB ]
  11. 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 [ Time Frame: Days 15, 30, 60, and 90 post-CPB ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05746559


Contacts
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Contact: Alexion Pharmaceuticals, Inc. (Sponsor) 1-855-752-2356 clinicaltrials@alexion.com

Locations
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Sponsors and Collaborators
Alexion Pharmaceuticals, Inc.
More Information
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Responsible Party: Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05746559    
Other Study ID Numbers: D928DC00001
ALXN1210-CSA-AKI-318 ( Other Identifier: Alexion Pharmaceuticals, Inc. )
2022-501802-36 ( EudraCT Number )
First Posted: February 27, 2023    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals, Inc.:
Chronic Kidney Disease
CKD
Cardiac Disease
cardiopulmonary bypass
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
 Chronic Disease
Disease Attributes
Pathologic Processes
Cardiovascular Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs