Clinical Trial: Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation

Brief Summary: The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of Delayed Graft Function following deceased donor kidney transplantation. Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent IR injury in high risk recipients. This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation and once again 24 hours later in preventing delayed graft function in first adult recipients of deceased donor kidneys.

Detailed Summary:
Sponsor: Heeger, Peter, M.D.

Current Primary Outcome: Hemodialysis [ Time Frame: 7 days post-transplantation ]

The need of at least one dialysis treatment during the first 7 days after transplantation excluding: (i) requirement for a single dialysis session indicated for hyperkalemia (ii) hyperacute rejection, renal arterial and/or venous thrombosis, obstructive uropathy, recurrence of primary disease, and early thrombotic microangiopathy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Estimated Glomerular Filtration Rate (GFR) [ Time Frame: 6 months post-transplantation ]
    Estimated GFR as determined from the 4-variable MDRD (Modified Diet in Renal Disease) equation on days 7, 30, 90 and 180 post-transplantation
  • Hemodialysis [ Time Frame: 8 weeks post-transplantation ]
    Number of dialysis sessions at 30 days and 8 weeks post-transplantation
  • Primary Non-function [ Time Frame: 8 weeks post-transplantation ]
    The incidence of primary non-function (PNF) defined as the need for dialysis-dependency for more than 8 weeks
  • Graft Rejection [ Time Frame: 6 months post-transplantation ]
    Incidence of graft rejection within 6 months
  • Patient Survival [ Time Frame: 12 months post-transplantation ]
    Patient survival at 12 months post-transplantation
  • Graft Survival [ Time Frame: 12 months post-transplantation ]
    Death censored graft survival at 12 months post-transplantation
  • Serum Creatinine [ Time Frame: 3 days post-transplantation ]
    Change from baseline in serum creatinine and serum creatinine concentration at 24, 48 and 72 hours post-transplantation
  • Urine Output [ Time Frame: 3 days post-transplantation ]
    Percentage of patients with total 24-hour urine output of more than 500 mL on post-transplantation days 2 and 3
  • Biomarkers [ Time Frame: 6 months post-transplantation ]
    Absolute levels of biomarkers associated with acute renal injury
  • Qualified Delayed Graft Function (qDGF) [ Time Frame: 7 days post-transplantation ]
    The incidence of qDGF defined as the requirement for dialysis for any reason in the first 7 days post-transplantation


Original Secondary Outcome:

  • Estimated Glomerular Filtration Rate (GFR) [ Time Frame: 6 months post-transplantation ]
    Estimated GFR as determined from the 4-variable MDRD (Modified Diet in Renal Disease) equation on days 7, 30, 90 and 180 post-transplantation
  • Hemodialysis [ Time Frame: 8 weeks post-transplantation ]
    Number of dialysis sessions in the 8 weeks post-transplantation period
  • Primary Non-function [ Time Frame: 8 weeks post-transplantation ]
    The incidence of primary non-function (PNF) defined as the need for dialysis-dependency for more than 8 weeks
  • Graft Rejection [ Time Frame: 6 months post-transplantation ]
    Incidence of graft rejection within 6 months
  • Patient Survival [ Time Frame: 12 months post-transplantation ]
    Patient survival at 12 months post-transplantation
  • Graft Survival [ Time Frame: 12 months post-transplantation ]
    Death censored graft survival at 12 months post-transplantation
  • Serum Creatinine [ Time Frame: 3 days post-transplantation ]
    Change from baseline in serum creatinine and serum creatinine concentration at 24, 48 and 72 hours post-transplantation
  • Urine Output [ Time Frame: 3 days post-transplantation ]
    Percentage of patients with total 24-hour urine output of more than 500 mL on post-transplantation days 2 and 3
  • Biomarkers [ Time Frame: 6 months post-transplantation ]
    Absolute levels of biomarkers (Ngal, Kim-1, IL-18) associated with acute renal injury


Information By: Heeger, Peter, M.D.

Dates:
Date Received: August 7, 2013
Date Started: August 2013
Date Completion: December 2018
Last Updated: February 22, 2017
Last Verified: February 2017