Clinical Trial: Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation

Brief Summary: The purpose of this study is to determine if Eculizumab is safe and could be used to prevent delayed graft function following kidney transplantation.

Detailed Summary:
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome: Incidence of DGF defined as the requirement for dialysis for any reason in the first seven days post-transplant [ Time Frame: First 7 days post Kidney Transplant ]

The primary objective is to demonstrate efficacy and safety of a two dose regimen of eculizumab to prevent DGF in adult recipients of diseased donor kidney transplants who are at increased risk of DGF.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function [ Time Frame: During the first 7 days post-transplantation ]
  • Dialysis post-transplantation [ Time Frame: During the first 30 days post-transplantation ]
  • Calculated eGFR (Estimated Glomerular Filtration Rate) [ Time Frame: At day 28 post-transplantation ]
  • Rejection free graft survival [ Time Frame: At 26 and 52 weeks post-transplantation ]
    Rejection free graft survival defined as not having biopsy proven acute rejection, graft loss or subject death


Original Secondary Outcome:

  • Graft function categorized into delayed graft function, functional delayed graft function, and immediate graft function [ Time Frame: During the first 7 days post-transplantation ]
  • Dialysis post-transplantation [ Time Frame: During the first 30 days post-transplantation ]
  • Calculated eGFR (Estimated Glomerular Filtration Rate) [ Time Frame: At day 28 post-transplantation ]
  • Rejection free graft survival [ Time Frame: At 26 and 52 weeks post-transplantation ]
    Rejection free graft survival defined as freedom from biopsy proven acute rejection, graft loss or subject death


Information By: Alexion Pharmaceuticals

Dates:
Date Received: May 15, 2014
Date Started: July 2014
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017