Urology: Clinical Research Program

Urology: Clinical Studies Open For Enrollment

• 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
  

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

Eligibility

• Male or female, 18 Years to 90 Years
• 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
• 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
    

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05746559

Principal Investigator

Cary Passik, MD

Contact for Study Screening

Danielle.Hansen@wmchealth.org