The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.
AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
450
Participants will receive ravulizumab via intravenous (IV) infusion.
Participants will receive placebo via intravenous (IV) infusion.
Research Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
San Francisco, California, United States
WITHDRAWNResearch Site
San Francisco, California, United States
Time to Freedom from Dialysis
Time frame: Through 90 days post-transplant
DGF Incidence
Time frame: Up to 7 days post-transplant
Number of Dialysis Sessions
Time frame: Through 90 days post-transplant
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
Time frame: Through 90 days post-transplant
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Research Site
Stanford, California, United States
RECRUITINGResearch Site
New Haven, Connecticut, United States
RECRUITINGResearch Site
Jacksonville, Florida, United States
RECRUITINGResearch Site
Tampa, Florida, United States
RECRUITINGResearch Site
Atlanta, Georgia, United States
RECRUITINGResearch Site
Chicago, Illinois, United States
RECRUITING...and 119 more locations