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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

NCT06830798

RecruitingPhase 3

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Delayed Graft Function, DGF, Kidney Transplant

Interventions: Ravulizumab, Placebo

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (130)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • New Haven, Connecticut, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Fairway, Kansas, United States
  • Lexington, Kentucky, United States
  • Kenner, Louisiana, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Livingston, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Greenville, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Charlottesville, Virginia, United States
  • Richmond, Virginia, United States
  • + 100 more on CT.gov