Clinical trial NCT06830798: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Delayed Graft Function
DGF
Kidney Transplant
Keywords: Delayed Graft Function
DGF
Kidney Transplant
Ravulizumab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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:

  1. Donation after Circulatory Death (DCD) donor
  2. 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.

Primary outcomes:
measure: Time to Freedom from Dialysis
timeFrame: Through 90 days post-transplant
Secondary outcomes:
measure: DGF Incidence
timeFrame: Up to 7 days post-transplant
measure: Number of Dialysis Sessions
timeFrame: Through 90 days post-transplant
measure: Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
timeFrame: Through 90 days post-transplant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Fairway
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Kenner
country: United States
facility: Research Site
state: Louisiana
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Livingston
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Adelaide
country: Australia
facility: Research Site
city: Brisbane
country: Australia
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
city: Murdoch
country: Australia
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Botucatu
country: Brazil
facility: Research Site
city: Bragança Paulista
country: Brazil
facility: Research Site
city: Campinas
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São José do Rio Preto
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Guangzhou
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Hradec Kralova
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Montpellier cedex 5
country: France
facility: Research Site
city: Nantes cedex 1
country: France
facility: Research Site
city: Paris Cedex 13
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Mainz Am Rhein
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Foligno
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisbon
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barakaldo
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cádiz
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Woodville South
country: United Kingdom
facility: Research Site
Study officials:
References: