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 (AWAKE)

Alexion Pharmaceuticals

Status and phase: Begins enrollment this month; Phase 3

Conditions: Kidney Transplant; DGF; Delayed Graft Function

Treatments: Drug: Placebo; Drug: Ravulizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06830798

2024-517568-48 (EudraCT Number)

D928EC00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 2 patient groups, including a placebo group

Ravulizumab

Experimental group

Description:

Participants will receive an IV dose of ravulizumab.

Treatment:

Drug: Ravulizumab

Placebo

Placebo Comparator group

Description:

Participants will receive an IV dose of placebo.

Treatment:

Drug: Placebo