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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delayed Graft Function
• DGF
• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Ravulizumab	Participants will receive ravulizumab via intravenous (IV) infusion.
DRUG	Placebo	Participants will receive placebo via intravenous (IV) infusion.

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-02-04
• Completion: 2028-11-06
• First posted: 2025-02-17
• Last updated: 2026-04-16

Locations

130 sites across 18 countries: United States, Argentina, Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study