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

Talk to us

Conditions

Delayed Graft FunctionDGFKidney TransplantRavulizumab

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-05-30
Study Completion:2028-11-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830798

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age at the time of signing the informed consent
  2. * Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
  3. * A candidate for kidney transplant from:
  4. 1. Donation after Circulatory Death (DCD) donor
  5. 2. High-risk Donation after Brain Death (DBD) donor
  1. * Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification
  2. * Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85054
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
San Francisco, California, 94115
United States
Research Site
San Francisco, California, 94143
United States
Research Site
New Haven, Connecticut, 06519
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Tampa, Florida, 33606
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60608
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Fairway, Kansas, 66205
United States
Research Site
Lexington, Kentucky, 40508
United States
Research Site
Kenner, Louisiana, 70065
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Minneapolis, Minnesota, 55455
United States
Research Site
Saint Louis, Missouri, 63108
United States
Research Site
Omaha, Nebraska, 68198
United States
Research Site
Livingston, New Jersey, 07039
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10065
United States
Research Site
Durham, North Carolina, 27705
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Greenville, South Carolina, 29605
United States
Research Site
Nashville, Tennessee, 37232
United States
Research Site
Dallas, Texas, 75235
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Richmond, Virginia, 23298
United States
Research Site
Seattle, Washington, 98104
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2028-11-21

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2028-11-21

Terms related to this study

Keywords Provided by Researchers

  • Delayed Graft Function
  • DGF
  • Kidney Transplant
  • Ravulizumab

Additional Relevant MeSH Terms

  • Delayed Graft Function
  • DGF
  • Kidney Transplant