Not currently recruiting at UCLA

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 Los Angeles, California and other locations
Dates
study started
study ends around
Principal Investigator
by Suphamai Bunnapradist, MD, MS
Headshot of Suphamai Bunnapradist
Suphamai Bunnapradist

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 not yet accepting patients
    Los Angeles California 90095 United States
  • Research Site not yet accepting patients
    Stanford California 94305 United States
  • Research Site accepting new patients
    Seattle Washington 98104 United States
  • Research Site accepting new patients
    Dallas Texas 75235 United States

Lead Scientist at UCLA

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT06830798
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated
Contact us about this trial