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

NCT05746559

TerminatedPhase 3

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass

Interventions: Placebo, Ravulizumab

Countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (130)
  • Orange, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Kansas City, Missouri, United States
  • Rochester, New York, United States
  • Valhalla, New York, United States
  • Fargo, North Dakota, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Dallas, Texas, United States
  • Charlottesville, Virginia, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Corrientes, Argentina
  • Santa Fe, Argentina
  • Brisbane, Australia
  • Monash, Australia
  • Murdoch, Australia
  • Southport, Australia
  • Belo Horizonte, Brazil
  • Fortaleza, Brazil
  • Recife, Brazil
  • Ribeirão Preto, Brazil
  • Rio de Janeiro, Brazil
  • + 100 more on CT.gov