This study is not yet accepting patients

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 study on Delayed Graft Function DGF Kidney Transplant Transplants

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Delayed Graft Function, DGF, Kidney Transplant, Ravulizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 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

You CAN'T join if...

  • 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.

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    San Francisco California 94143 United States
  • Research Site
    San Francisco California 94115 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
ID
NCT06830798
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated