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
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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:
- Donation after Circulatory Death (DCD) donor
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06830798
Intervention or treatment
DRUG: Ravulizumab
DRUG: Placebo
Conditions
- Delayed Graft Function
- DGF
- Kidney Transplant
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
Adelaide, Australia
Research Site
Brisbane, Australia
Research Site
Camperdown, Australia
Research Site
Murdoch, Australia
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Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Ravulizumab
| Drug: Ravulizumab |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Time to Freedom from Dialysis | Not Specified | Through 90 days post-transplant |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| DGF Incidence | Not Specified | Up to 7 days post-transplant |
| Number of Dialysis Sessions | Not Specified | Through 90 days post-transplant |
| Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2 | Not Specified | Through 90 days post-transplant |
References
Clinical Trials Gov: 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 TransplantationOther trials to consider
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