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

Study Identifier:
D928DC00001
ClinicalTrials.gov Identifier:
NCT05746559
EudraCT Identifier:
2022-501802-36
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Placebo
  • Drug: Ravulizumab
Date
Apr 2023 - May 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 90 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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.
Sex
Female & Male
Age
18 - 90 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Placebo
  • Drug: Ravulizumab
Date
Apr 2023 - May 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 90 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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.

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Tucson, Arizona, United States, 85719
Status
N/A
Location
Research Site
Orange, California, United States, 92868
Status
N/A
Location
Research Site
San Francisco, California, United States, 94121
Status
N/A
Location
Research Site
San Francisco, California, United States, 94143
Status
N/A
Location
Research Site
Stanford, California, United States, 94305
Status
N/A
Location
Research Site
Aurora, Colorado, United States, 80045
Status
N/A
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