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

Description

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.

Conditions

Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Tucson

Research Site, Tucson, Arizona, United States, 85719

Orange

Research Site, Orange, California, United States, 92868

San Francisco

Research Site, San Francisco, California, United States, 94121

San Francisco

Research Site, San Francisco, California, United States, 94143

Stanford

Research Site, Stanford, California, United States, 94305

Aurora

Research Site, Aurora, Colorado, United States, 80045

Washington

Research Site, Washington, District of Columbia, United States, 20037-2342

Gainesville

Research Site, Gainesville, Florida, United States, 32610

Orlando

Research Site, Orlando, Florida, United States, 32804

Weston

Research Site, Weston, Florida, United States, 33331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2027-02-17