RECRUITING

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

Description

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 Overview

Study Details

Study 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.

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

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

Condition
Delayed Graft Function
Intervention / Treatment

-

Contacts and Locations

Phoenix

Research Site, Phoenix, Arizona, United States, 85054

Los Angeles

Research Site, Los Angeles, California, United States, 90095

San Francisco

Research Site, San Francisco, California, United States, 94115

San Francisco

Research Site, San Francisco, California, United States, 94143

New Haven

Research Site, New Haven, Connecticut, United States, 06519

Jacksonville

Research Site, Jacksonville, Florida, United States, 32224

Tampa

Research Site, Tampa, Florida, United States, 33606

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Chicago

Research Site, Chicago, Illinois, United States, 60608

Chicago

Research Site, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2028-11-21