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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06830798

Acronym

AWAKE

Enrollment

450

Registered

2025-02-17

Start date

2025-05-19

Completion date

2028-08-30

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Graft Function, DGF, Kidney Transplant

Keywords

Delayed Graft Function, DGF, Kidney Transplant, Ravulizumab

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.

Detailed description

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.

Interventions

DRUGRavulizumab

Participants will receive ravulizumab via intravenous (IV) infusion.

DRUGPlacebo

Participants will receive placebo via intravenous (IV) infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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: 1. Donation after Circulatory Death (DCD) donor 2. 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.

Design outcomes

Primary

Measure	Time frame
Time to Freedom from Dialysis	Through 90 days post-transplant

Secondary

Measure	Time frame
DGF Incidence	Up to 7 days post-transplant
Number of Dialysis Sessions	Through 90 days post-transplant
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2	Through 90 days post-transplant

Countries

Argentina, Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

CONTACTAlexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com1-855-752-2356

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026