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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ravulizumab, Placebo.
- Who it may be relevant to
- Registry conditions: Delayed Graft Function, DGF, Kidney Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Brazil +13
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
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.
Interventions
- Drug Ravulizumab
Participants will receive ravulizumab via intravenous (IV) infusion. - Drug Placebo
Participants will receive placebo via intravenous (IV) infusion.
Primary outcome measures
- Time to Freedom from Dialysis [Time frame: Through 90 days post-transplant]
Secondary outcome measures (3)
- DGF Incidence [Time frame: Up to 7 days post-transplant]
- Number of Dialysis Sessions [Time frame: Through 90 days post-transplant]
- Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2 [Time frame: Through 90 days post-transplant]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- Research Site — Phoenix
- Research Site — Los Angeles
- Research Site — San Francisco
- Research Site — San Francisco
- Research Site — Stanford
- Research Site — New Haven
- Research Site — Jacksonville
- Research Site — Tampa
- … and 24 more centers
Spain · 15 centers
Center list to be confirmed — check the primary protocol.
Brazil · 12 centers
- Research Site — Belo Horizonte
- Research Site — Belo Horizonte
- Research Site — Botucatu
- Research Site — Botucatu
- Research Site — Campinas
- Research Site — Fortaleza
- Research Site — Porto Alegre
- Research Site — Porto Alegre
- … and 4 more centers
China · 11 centers
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Hangzhou
- Research Site — Hengyang
- Research Site — Nanning
- Research Site — Shenzhen
- Research Site — Taiyuan
- … and 3 more centers
France · 7 centers
- Research Site — Créteil
- Research Site — La Rochelle
- Research Site — La Tronche
- Research Site — Montpellier
- Research Site — Nantes
- Research Site — Paris
- … and 1 more center
Italy · 6 centers
Center list to be confirmed — check the primary protocol.
Argentina · 5 centers
- Research Site — Buenos Aires
- Research Site — Buenos Aires
- Research Site — Buenos Aires
- Research Site — Capital Federal
- Research Site — Córdoba
Canada · 5 centers
- Research Site — Edmonton
- Research Site — Vancouver
- Research Site — Toronto
- Research Site — Toronto
- Research Site — Montreal
Germany · 5 centers
Center list to be confirmed — check the primary protocol.
Portugal · 5 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Australia · 4 centers
- Research Site — Adelaide
- Research Site — Brisbane
- Research Site — Camperdown
- Research Site — Murdoch
Poland · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Czechia · 3 centers
- Research Site — Hradec Kralova
- Research Site — Ostrava
- Research Site — Prague
South Korea · 3 centers
Center list to be confirmed — check the primary protocol.
Austria · 2 centers
- Research Site — Innsbruck
- Research Site — Vienna
Japan · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06830798 · D928EC00001 · 2024-517568-48