Alexion ECU-DGF-201

Protocol: 
AAAN8450
Phase: 
II

A randomized, parallel-group, double-blind, placebo-controlled, multi-center study of eculizumab for the prevention of delayed graft function after kidney transplantation in adult subjects at increased risk of delayed graft function.

Purpose

A trial to determine if eculizumab is safe and could be used to prevent Delayed Graft Function after kidney transplantation.

Description

Delayed Graft Function (DGF) is an early complication of organ transplantation, which consists of the failure of an organ to function when it is initially transplanted.  Most often DGF results from ischemia/reperfusion injury (IRI), a complex pathological process that is a consequence of organ preservation.

The primary objective of this study is to demonstrate efficacy and safety of a two dose regimen of eculizumab to prevent DGF in adult patients undergoing deceased-donor kidney transplantation and who are at increased risk of DGF.

The study will consist of a primary study period through 26 weeks and a follow-up period through 52 weeks. Transplant recipients will be randomized prior to transplant surgery to receive either eculizumab or placebo (normal saline).

Are you Eligible? (Inclusion Criteria)

  • Dialysis dependent
  • To receive first kidney transplant
  • Has not had any prior transplant
  • BMI <40 kg/m2
  • Has a predicted Irish model risk of DGF ≥ 25
  • No history of HIV or active hepatitis C or hepatitis B infection
  • No current cancer or history of cancer within the past 5 years

Specialty Area(s)

Trial Location

Columbia University Medical Center
United States