ACTIVE_NOT_RECRUITING

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

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Conditions

Chronic Kidney DiseaseCKDCardiac DiseaseCardiopulmonary Bypass

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-04-06
Study Completion:2027-02-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05746559

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant weighs ≥ 30 kg
  2. * Planned non-emergent sternotomy with CPB procedure for the following surgeries:
  3. * Multi-vessel CABG
  4. * Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
  5. * Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
  6. * Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
  1. * Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator.
  2. * Single-vessel CABG without valve surgery is planned.
  3. * Off-pump surgery is planned (eg, surgery without CPB).
  4. * Recipient of a solid organ or bone marrow transplantation.
  5. * Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
  6. * Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
  7. * History of unexplained, recurrent infection.
  8. * Any use of KRT or presence of AKI within 30 days of randomization
  9. * 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.
  10. * Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics , if needed
  11. * History of or unresolved N meningitidis infection.

Contacts and Locations

Study Locations (Sites)

Research Site
Tucson, Arizona, 85719
United States
Research Site
Orange, California, 92868
United States
Research Site
San Francisco, California, 94121
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Stanford, California, 94305
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Weston, Florida, 33331
United States
Research Site
Atlanta, Georgia, 30309
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Indianapolis, Indiana, 46237
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Springfield, Massachusetts, 01107
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
Kansas City, Missouri, 64111
United States
Research Site
St Louis, Missouri, 63110
United States
Research Site
Rochester, New York, 14621
United States
Research Site
Valhalla, New York, 10595
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Fargo, North Dakota, 58102
United States
Research Site
Cleveland, Ohio, 44126
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Charleston, South Carolina, 29425
United States
Research Site
Dallas, Texas, 75390
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Salt Lake City, Utah, 84132
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Richmond, Virginia, 23298
United States
Research Site
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-06
Study Completion Date2027-02-17

Study Record Updates

Study Start Date2023-04-06
Study Completion Date2027-02-17

Terms related to this study

Keywords Provided by Researchers

  • Chronic Kidney Disease
  • CKD
  • Cardiac Disease
  • Cardiopulmonary Bypass

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • CKD
  • Cardiac Disease
  • Cardiopulmonary Bypass