Ravulizumab in High Risk of Delayed Graft Function Kidneys - Alexion AWAKE - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called ravulizumab (the study drug) is a safe and effective option to prevent or reduce the severity of delayed graft function after people with end-stage kidney disease (ESKD) get a kidney transplant.
Delayed Graft Function after Kidney Transplant in Patients with End-Stage Kidney Disease (ESKD)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with ESKD
- Are a candidate to receive a kidney transplant from a deceased donor
- Have been on dialysis for at least 1 year
For more information, contact the study team at jerry.turner@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to get either the study drug or a placebo. A placebo is an inactive substance given in the same form as the study drug. The study drug or placebo will be given via intravenous (IV) infusion approximately 24 hours to 30 minutes before your kidney transplant. You will get a single dose of the study drug or placebo.
You will come back to our clinic for 13 follow-up visits during the first 3 months after your transplant. After the first 3 months following your transplant, you will visit us once every 3 months for a check-up. Your participation in the study will end 1 year after your transplant.
Most of your follow-up visits will be at times when you will be seeing your transplant doctor for routine visits. Tests and procedures during these visits will include physical exams, questionnaires, and blood and urine tests.
Study Details
