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:
1-855-752-2356 or [email protected]
Recruiting

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
  • 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
  • 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
Recruiting
Location
Research Site
Orange, California, United States, 92868
Status
Recruiting
Location
Research Site
San Francisco, California, United States, 94121
Status
Suspended
Location
Research Site
San Francisco, California, United States, 94143
Status
Recruiting
Location
Research Site
Stanford, California, United States, 94305
Status
Recruiting
Location
Research Site
Aurora, Colorado, United States, 80045
Status
Recruiting
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