At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ravulizumab (drug), Placebo (drug)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- Ravulizumab — drug: Participants will receive ravulizumab via intravenous (IV) infusion. · Placebo — drug: Participants will receive placebo via intravenous (IV) infusion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a medicine called ravulizumab, given through a drip into a vein, in adults having a kidney transplant who are at high risk of a problem called delayed graft function. This is when the new kidney does not work straight away after transplant. The study is funded by Alexion Pharmaceuticals, Inc., and compares ravulizumab with a dummy medicine (placebo), with neither the participant nor the study team knowing which is which.
Who can take part
- Adults aged 18 or over
- People with end-stage kidney disease who need dialysis
- People waiting for a kidney from a donor whose death was confirmed by their heart stopping, or from a higher-risk donor whose death was confirmed by brain tests
Who may not be able to
- People receiving a kidney from a donor in certain groups of the Maastricht classification (categories I, II, IV and V) — ask the trial team what this means
- People with the most severe stage (Stage 3) of sudden kidney injury, as defined by international kidney guidelines
What taking part involves
- • Receiving ravulizumab or a dummy medicine (placebo) through a drip into a vein
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 450
- Started
- 2025-05-19
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for delayed graft function
- • Phase3 - 450 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with delayed graft function
Where?
- • Leeds - Research Site
- • London - Research Site
- • London - Research Site
- • London - Research Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓≥ 18 years of age at the time of signing the agreement to take part
- ✓Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
- ✓A candidate for kidney transplant from:
- ✓Donation after Circulatory Death (DCD) donor
- ✓High-risk Donation after Brain Death (DBD) donor
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (5 UK sites)
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London E1 1BB, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
Woodville South 5011, United Kingdom
How to Get in Touch
Alexion Pharmaceuticals, Inc. (Sponsor)
Sponsor contactCONTACT