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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

≥ 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 Criteria:

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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