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

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Alexion Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Chronic Kidney Disease
Cardiac Disease
CKD
Cardiopulmonary Bypass

Treatments

Drug: Placebo
Drug: Ravulizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05746559
2022-501802-36 (EudraCT Number)
ALXN1210-CSA-AKI-318 (Other Identifier)
D928DC00001

Details and patient eligibility

About

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.

Enrollment

736 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

736 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
Treatment:
Drug: Placebo
Ravulizumab
Experimental group
Description:
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
Treatment:
Drug: Ravulizumab

Trial contacts and locations

174

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Central trial contact

Alexion Pharmaceuticals, Inc. (Sponsor)

Data sourced from clinicaltrials.gov

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