Ravulizumab for Kidney Transplant

(AWAKE Trial)

Recruiting at97 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alexion Pharmaceuticals, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

Eligibility Criteria

This trial is for adults at high risk of delayed graft function (DGF) after receiving a kidney transplant from a deceased donor. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am eligible for a kidney transplant from a high-risk donor.

I am eligible for a kidney transplant from a donor after circulatory death.

I am 18 years old or older.

Exclusion Criteria

My kidney donor matches specific criteria.

I have been diagnosed with severe acute kidney injury.

Treatment Details

Interventions

• Ravulizumab (Monoclonal Antibodies)

Trial Overview The study aims to test if Ravulizumab can reduce the severity of DGF compared to a placebo. It measures how long it takes patients to be free from dialysis post-transplant. Participants will be randomly assigned to receive either Ravulizumab or placebo in a double-blind manner.

Participant Groups

Group I: Ravulizumab Experimental Treatment 1 Intervention

Participants will receive an IV dose of ravulizumab.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive an IV dose of placebo.

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials

267

Recruited

141,000+

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology