RecruitingPHASE3INTERVENTIONAL

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

This research study, called AWAKE, is testing a new medication named ravulizumab. It's for adults who are having a kidney transplant from a deceased donor and are at a higher risk of their new kidney not working properly straight away, a problem known as Delayed Graft Function (DGF). DGF can mean needing dialysis after the transplant. The main goal is to find out if ravulizumab can help these patients avoid or reduce the time they need dialysis, allowing their new kidney to function sooner. Some patients will receive ravulizumab, while others will receive a dummy treatment (placebo), to fairly compare the medicine's effects. The study also checks how safe the medicine is.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

450

Start

19 May 2025

Estimated completion

06 Nov 2028

Delayed Graft Function DGF Kidney Transplant

What is this study about?

When someone receives a new kidney, especially from a deceased donor, sometimes the new kidney doesn't start working properly right after the operation. This is called Delayed Graft Function, or DGF. It can mean that the patient still needs dialysis for a while until their new kidney 'wakes up' and starts filtering their blood by itself. This can be a challenging time, and doctors are always looking for ways to help the new kidney get up and running as quickly and smoothly as possible.

This study is looking at an experimental medicine called ravulizumab. The idea is that this medicine might help protect the new kidney and encourage it to work faster, reducing the time a patient might need to be on dialysis after their transplant. Finding a way to reduce DGF could make the recovery process easier and quicker for many patients after a kidney transplant.

The study is designed to be very careful and fair. Some patients will receive the ravulizumab medicine, and others will receive a 'placebo', which looks identical but contains no active medicine. This allows researchers to accurately compare whether ravulizumab truly makes a difference compared to not receiving the active drug. Everything is done to ensure patient safety and ethical research practices.

Key takeaways

Tests a new medicine (ravulizumab) for kidney transplant patients.
Aims to help new kidneys work faster, reducing the need for dialysis.
For adults receiving kidneys from deceased donors.
Compares ravulizumab to a placebo (dummy treatment).
Focuses on safety and how well the medicine works.
You can choose to leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who need a kidney transplant because their own kidneys have failed completely and they rely on dialysis. Specifically, they must be receiving a kidney from a deceased donor. This means the donor's heart had either stopped (called Donation after Circulatory Death) or their brain had stopped working (high-risk Donation after Brain Death).

There are also some reasons why you wouldn't be able to join. For example, if the donor kidney has certain issues (based on specific medical categories) or if you have very severe acute kidney injury (a sudden kidney problem) at the time of considering the study, you might not be eligible.

Quick self-check

Am I 18 years old or older?
Do I have kidney failure requiring dialysis?
Am I a candidate for a kidney transplant from a deceased donor (either circulatory death or high-risk brain death)?
Have I recently had a very severe sudden kidney injury?
Is my deceased donor's kidney from certain 'Maastricht' categories (which might exclude me)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the study medicine, ravulizumab, or a placebo (a dummy treatment). This would be given into your vein (intravenously). You would have regular check-ups, blood tests, and other assessments before, during, and after your kidney transplant to monitor your health and how your new kidney is working. The healthcare team will keep a close eye on you to see if the medicine is helping your kidney recover and to check for any side effects. The total duration of your involvement in the study, including follow-up appointments, would be explained fully by the study team, but it would involve several visits over a period after your transplant.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit if ravulizumab helps your new kidney start working sooner, reducing your time on dialysis. However, there's no guarantee the medicine will work for you, and it's also possible you could be given the placebo. As with any medicine, there's a chance of side effects or unexpected reactions. The doctors and nurses involved in the study will explain all known risks and monitor you closely. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (130)

Research Site
Phoenix, United States· Recruiting
Research Site
Los Angeles, United States· Recruiting
Research Site
San Francisco, United States· Withdrawn
Research Site
San Francisco, United States· Recruiting
Research Site
Stanford, United States· Recruiting
Research Site
New Haven, United States· Recruiting
Research Site
Jacksonville, United States· Recruiting
Research Site
Tampa, United States· Recruiting
Research Site
Atlanta, United States· Recruiting
Research Site
Chicago, United States· Recruiting
Research Site
Chicago, United States· Recruiting
Research Site
Fairway, United States· Recruiting

+118 more sites — see the official record for the full list.

Common questions

What is Delayed Graft Function (DGF)?

DGF is when a new kidney doesn't start working immediately after a transplant, meaning the patient might still need dialysis temporarily.

What is ravulizumab?

Ravulizumab is an investigative medicine being tested to see if it can help new kidneys work faster after a transplant.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctors will know whether you are receiving ravulizumab or the placebo.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and your medical care will not be affected.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com 1-855-752-2356 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.