Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
Alexion Pharmaceuticals, Inc.
450 participants
Feb 24, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- ≥ 18 years of age at the time of signing the informed consent
- Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
- A candidate for kidney transplant from:
- Donation after Circulatory Death (DCD) donor
- High-risk Donation after Brain Death (DBD) donor
Exclusion Criteria2
- Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification
- Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
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Interventions
Participants will receive ravulizumab via intravenous (IV) infusion.
Participants will receive placebo via intravenous (IV) infusion.
Locations(130)
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NCT06830798