Clinical Trial: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

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

Official Title: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection

Brief Summary: The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome: CMV infection [ Time Frame: 2 years ]

Incidence of any clinically significant late CMV infection: including disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days after 200 days post-transplant


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Early CMV infection [ Time Frame: 100 days ]
  • cell mediated immunity [ Time Frame: 2 years ]
  • renal function [ Time Frame: 2 years ]
    Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant
  • Incidence and severity of acute cellular and/or antibody mediated rejection [ Time Frame: 2 years ]
  • Incidence of post-transplant diabetes mellitus [ Time Frame: 2 years ]
  • Incidence and severity of opportunistic infections [ Time Frame: 2 years ]
  • Incidence of asymptomatic CMV viremia [ Time Frame: 2 years ]
  • Incidence of CMV seroconversion [ Time Frame: 2 years ]
  • Drug cost comparison [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Early CMV infection [ Time Frame: 100 days ]
  • cell mediated immunity [ Time Frame: 2 years ]
  • renal function [ Time Frame: 2 years ]
    Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated MDRD equation at 6, 12, and 24 months after transplant
  • Incidence and severity of acute cellular and/or antibody mediated rejection [ Time Frame: 2 years ]
  • Incidence of post-transplant diabetes mellitus [ Time Frame: 2 years ]
  • Incidence and severity of opportunistic infections [ Time Frame: 2 years ]
  • Incidence of asymptomatic CMV viremia [ Time Frame: 2 years ]
  • Incidence of CMV seroconversion [ Time Frame: 2 years ]
  • Drug cost comparison [ Time Frame: 2 years ]


Information By: Medical University of South Carolina

Dates:
Date Received: January 10, 2012
Date Started: November 2011
Date Completion:
Last Updated: February 12, 2016
Last Verified: December 2015