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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
736
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
Time frame: Day 90 post-CPB
To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB
1. Occurrence of CSA-AKI without recovery at Day 90 post CPB 2. Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB 3. Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB 4. Occurrence of KRT or death from randomization to Day 90 post CPB 5. All-cause mortality from randomization to Day 90 post CPB 6. Length of post-operative ICU stay
Time frame: Day 90 post CPB
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